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									               2008 – 2009
ARCS AUSTRALIA PROFESSIONAL
    DEVELOPMENT BROCHURE




   Professional Development
for the Therapeutics Industry™
I am pleased to provide you with the 2008 – 2009 ARCS Australia Professional
Development Brochure. The brochure is fast becoming the one stop shop for ARCS
members and industry professionals looking to address their professional development
needs. Browse it now, develop a Training Plan for you and/or your staff and keep it
handy to refer to the many Course Outlines and the Calendar of Courses.


    NEW IN 2008/9

Professional Development for Clinical Research Professionals – in Sponsor Companies and at Research Sites
The tried and tested courses are back with improvements based on the feedback provided by attendees/instructors. There is
something for everyone in the professional development pathway – from entry level positions to those involved in clinical project
management/project leadership.
This year sees new initiatives in:
•   Managing Clinical Trial Documentation – a half day workshop
•   A selection of short courses to be offered online via the ARCS website in 2009
•   ARCS and the University of Melbourne have partnered to deliver a Specialist Certificate in Clinical Research (Clinical Trials) with
    two streams for those involved in monitoring or co-ordinating clinical trials (to be offered in 2009).
Go to page 6 to read more about these initiatives and to pages 8 - 11 for relevant course outlines.




2      ARCS AUSTRALIA
Professional Development for Regulatory Affairs Professionals
This year sees the launch of the long awaited expansion to educational offerings for regulatory affairs professionals. For the first time,
ARCS is in a position to provide a comprehensive professional development pathway for those working within regulatory affairs (similar
to that introduced for clinical research professional last year). Again, we have something for everyone from entry level positions to
advanced modules/extracurricular programs. You will see five new courses being launched throughout 2008/9 which meet a variety of
needs – these courses include:
•   Drug Development and the Common Technical Document,
•   Requirements for Quality – Module 3 and Module 2.3
•   Clinical Pharmacology (Bioavailability and Bioequivalence), and
•   EU & USA Regulatory Affairs
Important in the professional development of those working within regulatory affairs is the training provided by the regulator and
relevant industry groups. This year ARCS is again working with the TGA to provide two TGA/Industry education days.
Go to page 12 to read more about these initiatives and to pages 14 - 17 for relevant course outlines.

Professional Development for Health Economists
Following great support in 2006 and 2007, ARCS will again be collaborating with the Pharmaceutical Evaluation Branch (PEB) for a
PBS Overview Day, to be held in Canberra. This seminar is intended to provide new industry professionals or those with an interest
in health economics an introduction and exposure to the PEB as well as grounding in the listing and pricing procedures. This will
be supported by technical seminars presented by PEB staff to provide updates and practical workshops related to the Guidelines
(scheduled as required). Go to page 19 for relevant course outlines.

Professional Development for Drug Safety/ Pharmacovigilance Professionals
Last year the Pharmacovigilance Educational Subcommittee (ESC) with the support of the ARCS Business Office released the first
introductory training module – An Introduction to Pharmacovigilance Requirements. In 2009, this course will be complemented by a
second module titled A Practical Course for Pharmacovigilance Professionals – a workshop developed and delivered by the senior
members of the Pharmacovigilance ESC.
Go to page 21 for relevant course outlines.

New Manager Course to complement Non-technical Professional Development
This year we have supplemented the already popular non-technical program with a New Manager Training Course. The non-technical
training program has been added to both the clinical and regulatory pathways but is applicable to ARCS members from all
educational areas.
Go to page 27 to read more about this new course and to pages 25 - 28 for the relevant course outlines.

A Note About Registration:
The planned dates for these workshops are located on the back pages of this brochure. The dates printed will be adhered to
whenever possible, with updates being communicated via the ARCS website and e-Bulletins. Registrations for all these events will
be taken online via our secure website at www.arcs.com.au and will open at least 6-8 weeks before the planned date for the event.
ARCS Australia is committed to ensuring advertised educational events go ahead. Early registration will assist us to assess the
interest for events in your State. With your support we are committed to delivering these events, so please submit your
registration early.
We hope this brochure will allow you to start planning and help you select courses relevant to your career goals and training needs.
If you have any questions regarding your suitability for any of the programs in this brochure, do not hesitate to contact the ARCS
Business Office on (02) 8905-0829.


Warm regards




Joseph Badolato PhD
Professional Development Manager
ARCS Australia




                                                      2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                      3
TABLE OF CONTENTS


    Professional Development Pathway for Clinical Research Professionals                                           6

    CRA1 - Essential GCP Training for New CRAs                                                                     8

    Conducting Clinical Research – Essential GCP Training for Study Coordinators                                   8

    CRA2 - Managing Your Trial Sites More Effectively                                                              9

    Managing Laboratories in Clinical Trials                                                                       9

    Understanding the GCP Audit Process                                                                           10

    Managing Common GCP Issues Effectively in Your Clinical Project                                               10

    How to Effectively Select Investigational Sites                                                               11

    Managing Clinical Trial Documentation – Essential GCP training – NEW COURSE                                   11

    Professional Development Pathway for Regulatory Affairs Professionals                                         12

    Introduction to Australian Regulatory Affairs                                                                 14

    The Drug Development Process and the Common Technical Document – NEW COURSE                                   14

    Requirements for Quality – Module 3 and Module 2.3 – NEW COURSE                                               15

    Applying Bioavailability and Bioequivalence (BABE) Guidelines – NEW COURSE                                    15

    Regulation of Pharmaceuticals in the European Union – NEW COURSE                                              16

    Regulation of Pharmaceuticals in the USA – NEW COURSE                                                         16

    Other Professional Development Opportunities for Regulatory Affairs Professionals                             17

    TGA Overview Day                                                                                              17

    TGA/Industry Update Day – NEW EVENT                                                                           17

    Industry Associations Annual Update                                                                           17

    Professional Development for Health Economists                                                                19

    An Introduction for the Process of Listing a Medicine on the Australian Pharmaceutical Benefits Scheme (PBS)   19

    A Practical Update on the PBAC Submission Guidelines                                                          19

    Professional Development for Drug Safety/Pharmacovigilance Professionals                                      21

    Introduction to Pharmacovigilance Requirements                                                                21

    A Practical Course for Pharmacovigilance Professionals – NEW COURSE                                           21

    ARCS / DIA Partnership Courses                                                                                22

    Overview of Drug Development                                                                                  22

    Practical Considerations in Drug Development                                                                  22

    Fundamentals of Project Management: What Everyone Involved in a Project Needs to Know                         23

    Project Management                                                                                            23

    Clinical Statistics for Nonstatisticians                                                                      24

    Advanced Clinical Statistics for Nonstatisticians                                                             24


4       ARCS AUSTRALIA
Non-Technical Professional Development Training                                                                                                 25

Managing and Resolving Conflict in the Workplace                                                                                                 25

Assertiveness Techniques for the Workplace                                                                                                      25

Dealing with Difficult People                                                                                                                    26

The Art of Negotiation                                                                                                                          26

Increasing your Effectiveness at Work                                                                                                           27

The New Manager Training Program – NEW COURSE                                                                                                   27

Business Writing Skills                                                                                                                         28

Advanced Business Writing Skills                                                                                                                28

Conferences and Other Educational Offering – Dates for the Diary                                                                                29

Annual General Education Meeting (AGEM)                                                                                                         29

Annual Scientific Congress 2009                                                                                                                  29

Melbourne Annual Dinner                                                                                                                         29

Calendar Dates                                                                                                                                  31




        Volunteering is an excellent way to promote professional
         development and broaden your network of colleagues

     ARCS Australia survives and continues to grow in strength and relevance as a result of our volunteers.
     Our volunteers are intimately involved with the 11 special interest groups and four regional networking groups and their contribution to
     the Association in directing our educational programs can never be over-estimated.
     We encourage all members to become involved, as it is by being involved that you gain the most from your professional membership.
     As a member, consider the following pathway from least to greatest commitment


                     Volunteer Activity                                                                   How?
                     Ask a question about a hot issue in your area of interest                            Via an ARCS Mailing List *
                     Propose a topic for a seminar, workshop or conference                                Via an ESC or Mailing List
                     Join an ESC or RGN – see WHY JOIN an ESC???                                          ** Below
                     Help organize a seminar or conference session                                        Join an ESC **
                     Join the ARCS speaker pool and be approached to speak at a seminar or confer-        Contact the ABO***
                     ence session on your area of expertise
                     Write an article for the ARCS Newsletter                                             Submit to ABO
                     Contribute to the ARCS Newsletter – Comment, Letter                                  Submit to ABO
                     Join an Education SubCommittee (ESC) Core Committee                                  Contact ESC Convenor
                     Chair a small seminar or larger conference session                                   Via an ESC or Mailing List
                     Become an ESC Convenor                                                               Elected from ESC
                     Facilitate an ARCS Training Course                                                   Application by tender
                     Join the ARCS Board                                                                  Nomination and election
                     Board President                                                                      Nomination and election
     * Join a Mailing List: Update Your Details on the website www.arcs.com.au
     ** Join an ESC: Contact the Convenor. Details on website and in Newsletter
     *** ABO: ARCS Business Office: arcs@arcs.com.au




                                                           2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                              5
PROFESSIONAL DEVELOPMENT PATHWAY
FOR CLINICAL RESEARCH PROFESSIONALS
This year ARCS is again pleased to provide a professional development pathway (see Table overleaf) for those working within the
clinical research educational area. This year the pathway is described in terms of typical developmental phases from entry level
positions through to roles involving clinical project management, at sponsor companies or at research sites. As in past years, the
suggested pathway is only a guide to how the courses on offer can assist in meeting current and future training needs. Training needs
and training solutions will be different from individual to individual and actual course selection should be done in consultation with
line management and with regard to your current and future roles and training needs. Please ensure you review all course information
available on the relevant training course before enrolling in any program.
Selected ARCS Clinical Short Courses Go Online in 2009
This year we are also pleased to be able to respond to the feedback from members to provide some professional development
opportunities online. Starting in 2009, a selection of ARCS courses including, “How to Effectively Select Investigational Sites” and
“Managing Clinical Trial Documentation” will be available as an online computer based training (CBT) module to ARCS members and
industry professionals via the ARCS website. Stay tuned throughout 2009 as we continue to explore which of the programs will be
made available to members in this way.
ARCS and the University of Melbourne Team up to Deliver a Specialist Certificate in Clinical Research (Clinical Trials)
ARCS is finalising a Specialist Certificate in Clinical Research (Clinical Trials) with the University of Melbourne. The Specialist
Certificate offers an integrated program that provides an opportunity for clinical research professionals to develop the skills required
to effectively coordinate or monitor interventional clinical trials. The Specialist Certificate will allow students undertaking workshops
offered by ARCS Australia anywhere in Australia to apply their knowledge in the workplace and have it assessed under the auspice of
the University of Melbourne. There will be a separate registration brochure sent to all members in July 2008.
Two streams of study will be offered, Trial Coordination and Trial Monitoring, which can be selected based on the work experience and
the professional development interest of students.
1. Trial Coordination: This stream will be of interest to clinical research professionals involved in the coordination and conduct of
   research in hospitals or clinics, or those seeking to move into this field who have a relevant work history, such as research nurses
   and data managers or
2. Trial Monitoring: This stream will be of interest to clinical research professionals involved in the set up, organisation, support and
   monitoring of sponsored single and multi site clinical trials, such as those overseeing research for pharmaceutical companies,
   research institutions, cooperative research centres, biotech companies, hospitals, clinics and other research institutions



6      ARCS AUSTRALIA
                                                              Clinical Site   Clinical Site     Clinical Project    Research Site
  COURSE NAME                                                 Monitoring      Management         Management             Staff

  Overview of Drug Development (1 day)                             ✓                                                      ✓
  CRA1 - Essential GCP Training for new CRAs (2 days)              ✓
  Conducting Clinical Research (CCR) – Essential GCP
  Training for Study Co-ordinators
                                                                                                                          ✓
  CRA2 - Managing Your Trial Sites More Effectively
  (2 days)
                                                                                    ✓
  Managing GCP Issues Effectively in Your Clinical Project
  (0.5 day)
                                                                                    ✓
  Fundamentals of Project Management: What Everyone
  Involved in a Project Needs to Know (1 day)
                                                                                                       ✓                  ✓
  An Introduction to Pharmacovigilance Requirements
  NEW COURSE (0.5 day)
                                                                   ✓                ✓                                     ✓
  Managing Clinical Trial Documentation
  – NEW COURSE (0.5 day)
                                                                   ✓                ✓                                     ✓
  How to Effectively Select Investigational Sites
  (CBT plus 0.5 day)
                                                                                    ✓
  Introduction to GCP Audits (2 days)                                               ✓                  ✓                  ✓
  Managing Laboratories in Clinical Trials (2 days)                                 ✓                                     ✓
  Clinical Statistics for Nonstatisticians (2 days)                                                    ✓                  ✓
  Project Management (3 days)                                                                          ✓
  The New Manager Training Program – NEW COURSE
  (2 days)
                                                                                                       ✓                  ✓
  Practical Considerations in Drug Development (3 days)                                                ✓
  Managing and Resolving Conflict (1 day)                           ✓                ✓                  ✓                  ✓
  Assertiveness Techniques for the Workplace (1 day)               ✓                ✓                                     ✓
  Dealing with Difficult People (1 day)                                              ✓                  ✓                  ✓
  The Art of Negotiation (1 day)                                                                       ✓                  ✓
  Increasing Your Effectiveness at Work (1 day)                    ✓                ✓                                     ✓
Any questions regarding the Professional Development opportunities outlined here for Clinical Research Professionals should be
directed to Joe Badolato at joebadolato@arcs.com.au.




                                                      2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                  7
    CRA1 - ESSENTIAL GCP TRAINING                                          CONDUCTING CLINICAL RESEARCH
    FOR NEW CRAS                                                           – ESSENTIAL GCP TRAINING FOR
                                                                           STUDY COORDINATORS
    Who Should Attend                                                      Who Should Attend
    • New CRAs who need more information about the typical roles,          • New coordinators looking for more information
      tasks and responsibilities of CRAs                                   • Individuals in an academic research capacity (including PhD
    • Site personnel, with experience in clinical research, interested       students, staff in pharmacy, laboratories staff etc) interested in
      in a better understanding of the CRA role                              how clinical research is coordinated
    • Those that do not have a clinical trial background who are           • Individuals looking for a toolkit to assist with coordinating
      seeking to broaden their understanding of the role of the CRA
                                                                             research at their hospital/clinic
    Course Overview                                                        • Individuals looking to share experience and learn from others
    Do you have questions about the role of the CRA in
                                                                           Course Overview
    clinical research? Do you need a good solid foundation
    in GCP? This introductory course covers the current regulatory         This course for study coordinators has been developed by an
    environment and drug development process and guides CRAs               Australian advisory board made up of individuals with over 100
    through their role in conducting studies in Australia and New          years of combined experience in coordinating clinical research
    Zealand. It will give you a solid introduction to the major areas to   at hospital sites. The course is full of practical coordination
    consider when conducting clinical research. It is essential training   tips from people that have been setting up research for years.
    for CRAs.                                                              The session is structured so that you will walk away with useful
                                                                           techniques, tools and tips to apply at your centre.
    Course Highlights
    Day 1                                                                  Course Highlights
    • Therapeutic goods and their regulation                               Day 1
    • Access to unapproved therapeutic goods                               Topics include:
    • The drug development process
    • Critical concepts in clinical development:                           • What type of research am I working on and what regulations
      • The clinical research process                                        should I follow?
      • Protocol development                                               • Understanding protocols
      • The CRA role                                                       • Where do I find my participants and how do I inform them?
      • Data generation                                                    • How do I plan for study visits
      • Analysis and reporting                                             • Source documents – pitfalls and strategies
    • GCP (ICH, WHO and others)                                            • How to manage investigational product and laboratory data
      • Declaration of Helsinki                                            • What is safety reporting and what is my role?
    • GCP “in action”                                                      • Useful study tools
    Day 2                                                                  Day 2
    • Review of ICH GCP
                                                                           This session will draw on the experience from our advisory
    • Adverse event management
                                                                           board as well as other attendees to develop strategies and
    • Getting a study started:
      • Site selection                                                     contingencies to a series of difficult clinical coordination
      • Clinical trial approvals                                           conundrums. Various “chestnuts” to be covered include:
      • Putting together an ethics submission                              •   What can I do to boost recruitment and retention?
    • Monitoring – the whole story…                                        •   What about consent in special participant populations?
      • Monitoring – what is it?                                           •   How do I demystify audits? What’s involved?
      • Useful tools, checklists & forms                                   •   Study design and methodology
      • Data clarification                                                  •   What can I do to improve my organisational skills?
      • Hands on experience! – an SDV exercise
                                                                           •   Communication strategies with your key customers
    • Audit and common issues
                                                                           Entry Criteria
    Entry Criteria
                                                                           This is an entry level/introductory course. There are no entry
    This is an entry level/introductory course. There are no entry
                                                                           criteria for this workshop. If you have any questions on your
    criteria for this workshop. If you have any questions on your
                                                                           suitability for this course, do not hesitate to call the ARCS
    suitability for this course, do not hesitate to call the ARCS
    Business Office on (02) 8905 0829.                                      Business Office on (02) 8905 0829.
    Type of Event: Workshop                                                Type of Event: Workshop
    Length of Event: 2 days                                                Length of Event: 2 days

    Dates                                                                  Dates
    Sydney: 19-Jun-08, 07-Aug-08, 15-Sep-08, 13-Nov-08,                    Sydney: 28-Aug-08, 26-Mar-09
    19-Feb-09, 02-Apr-09, 18-Jun-09                                        Melbourne: 30-Apr-09
    Melbourne: 14-Oct-08, 21-Apr-09
                                                                           Brisbane: 31-Jul-08, 30-Jul-09
    Brisbane: 29-Jul-08, 14-Jul-09


8       ARCS AUSTRALIA
                                          PROFESSIONAL DEVELOPMENT PATHWAY FOR CLINICAL RESEARCH PROFESSIONALS




CRA2 - MANAGING YOUR TRIAL                                           MANAGING LABORATORIES IN
SITES MORE EFFECTIVELY                                               CLINICAL TRIALS

Who Should Attend                                                    Who Should Attend
• Individuals with 12 months or more experience                      • CRAs, Senior CRAs, Project Managers,
  implementing clinical research looking to develop better           • Clinical Trial Coordinators, Data Managers
  site management skills                                             • Anyone involved in clinical research who needs a basic
• Experienced monitors looking to move into more                       understanding of laboratory testing for clinical trials
  senior positions                                                   Course Overview
• Individuals looking for a forum to discuss how different people
                                                                     ‘The objective of this course is to provide a comprehensive
  tackle typical problems encountered when implementing
                                                                     overview of laboratory testing procedures and as they are applied
  clinical trials
                                                                     to clinical trials of investigational drugs. By the end of the course,
Course Overview                                                      participants should be equipped with the information necessary
This is an intermediate course that builds on CRA1. It will help     to understand the role of laboratories in clinical research.
you improve your site management skills by starting with a high
level review of the ABCs of project management. The course           Course Highlights
then covers a number of challenges and strategies to effectively     Day 1
manage risk within key clinical trial processes to assist you get    The Laboratory:
the most from your trial sites.                                      • Pre-analytical factors – sample collection
Course Highlights                                                    • Standards and quality control
                                                                     • Quality assurance and laboratory accreditation
Day 1
                                                                     • Reference ranges
• Now that you’re more experienced, what should you be               • Case studies
  doing differently?
• Project management ABC’s                                           Day 2
• Things to consider when planning your site management.             •   Lab tour (half day)
• Risk with your project                                             •   Central vs. local labs
• Importance of study feasibility assessments                        •   Sample & courier logistics
• Site selection: how to apply your risk minimising strategies in    •   Collection kits
  an actual site selection visit                                     •   Packaging and transport
  • What are the typical steps and processes                         •   Managing data
  • What to ask and how to ask it                                    •   Reporting
• Managing the informed consent process                              •   Electronic data
Day 2:                                                               •   Project Management, IT & security
• Recruitment strategies and contingencies:                          •   Quality aspects
  • Common issues, tried solutions
                                                                     Entry Criteria
• Investigational product (IP) management
• Supporting your centers – applying management strategies           To get the most out of this course, you should have at least
  that work:                                                         12 months experience implementing or coordinating clinical
  • Conflict management                                               research. The course assumes you have some understanding
  • Effective communication                                          of the clinical trial process, relevant regulations and GCP. If you
  • Investigator training – what can I do to stand out from          have any questions on your suitability for this course, do not
  the crowd?                                                         hesitate to call the ARCS Business Office on (02) 8905 0829.
• Fraud and misconduct: - What is it? Does it happen?                Type of Event: Workshop
  • Common audit issues
                                                                     Length of Event: 2 days
  • Keeping the end in mind
Entry Criteria                                                       Dates
To get the most out of this course, you should have at least         This course will be advertised via the regular ARCS
12 months experience implementing and monitoring clinical            communication channels. It is expected that there will be
research. The course assumes you have some understanding of          scheduled courses in both Sydney and Melbourne in 2009.
the clinical trial process, relevant regulations and ICH-GCP.
Type of Event: Workshop
Length of Event: 2 days
Dates
Sydney: 17-Sep-08, 19-Mar-09
Melbourne: 16-Oct-08, 23-Apr-09
Brisbane: 17-Jul-08, 16-Jul-09


                                                       2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                           9
 UNDERSTANDING THE GCP                                                MANAGING COMMON GCP
 AUDIT PROCESS                                                        ISSUES EFFECTIVELY IN YOUR
                                                                      CLINICAL PROJECT
 Who Should Attend                                                    Who Should Attend
 • Clinical research professionals working in the                     • Individuals working within the clinical area with
   pharmaceutical/devices industry or who are based at                  approximately 1 - 2 years experience monitoring and/or
   investigator sites and have a good understanding of GCP              managing clinical trials.
   and the clinical research process                                  • Individuals who already have knowledge of GCP requirements,
 • Personnel whose clinical trials or departments are likely            but would like to feel more competent and confident in
   to be audited                                                        applying the principles to everyday issues.
 • Those with an interest in improving their quality management       • Those looking to share experience and learn from colleagues
   of clinical trials                                                   from different companies that may have a different perspective.
 • Those with an interest in improving their clinical trials          Course Overview
   process, particularly trial management and site activities         What is the rationale behind our clinical processes– and why
   such as monitoring                                                 do companies seem to interpret ICH / GCP differently? Have
 • Those who are interested in finding out what is involved in         you found yourself discussing the requirements for the “grey
   working as an auditor                                              areas” such as source documentation or informed consent with a
 Course Overview                                                      colleague or study coordinator and realised your practices differ?
 The course will raise awareness and provide a framework to           Have you debated requirements for Investigational Product or
 appreciate the different stages of audit processes and activities    Safety Reporting? Why do views differ? Who is right? Could you
 of GCP audits. This course will give you an interesting insight      both be right?
 into a “day in the life” of an auditor and provide you with some
 ideas to improve your monitoring and trial management. The           Course Highlights
 session will be applicable to those in the pharmaceutical/devices    This workshop session is intended to assist by:
 industry and institution-based research staff such as study          • Deconstructing clinical processes and reevaluating
 coordinators and investigators. Please note: It is not intended to     fundamental elements of GCP to determine
 act as a training course for auditors.                                 appropriate solutions
 Course Highlights                                                    • Using evidenced based problem solving and causality
 Day 1                                                                  assessment strategies in your decision making
                                                                      • Raising awareness of risk assessment when managing your
 •   Quality management                                                 clinical projects to implement appropriate corrective and
 •   Why do we audit?                                                   preventative actions
 •   Types of audits
 •   The auditor and the auditee                                      Come prepared to see those old “GCP chestnuts” from
                                                                      a different perspective, join into some thought provoking
 Day 2                                                                discussion and walk away with some tangible tips. The
 •   Audit preparation and conduct                                    workshop will use a number of case studies to illustrate the issue
 •   The audit feedback meeting                                       management principles. There will be time during the session
 •   Audit reporting                                                  for you to bring along your own GCP chestnuts and apply the
 •   Audit impacts and outcomes                                       principles discussed in situations you have encountered in your
                                                                      clinical studies.
 Entry Criteria
 The workshop will be a very interactive session that assumes         Entry Criteria
 you have 2 – 3 years experience in clinical research (basic          The course assumes that you have a good understanding of the
 aspects of ICH-GCP or the Australian regulatory framework will       clinical trial process, relevant regulations and ICH-GCP. If you
 not be covered). If you have any questions on your suitability for   have any questions on your suitability for this course, do not
 this course, do not hesitate to call the ARCS Business Office on      hesitate to call the ARCS Business Office on (02) 8905 0829.
 (02) 8905 0829.
                                                                      Type of Event: Workshop
 Type of Event: Workshop
                                                                      Length of Event: ½ day
 Length of Event: 2 days
                                                                      Dates
 Dates
                                                                      Sydney: 18-Jun-08, 11-Dec-08, 23-Jun-09
 Sydney: 17-Mar-09
 Melbourne: 26-Aug-08                                                 Melbourne: 04-Dec-08, 21-Jul-09
                                                                      Brisbane: 29-Jul-09




10     ARCS AUSTRALIA
                                           PROFESSIONAL DEVELOPMENT PATHWAY FOR CLINICAL RESEARCH PROFESSIONALS




HOW TO EFFECTIVELY SELECT                                             MANAGING CLINICAL TRIAL
INVESTIGATIONAL SITES                                                 DOCUMENTATION – ESSENTIAL
                                                                      GCP TRAINING
Who Should Attend                                                     Who Should Attend
• CRAs and Project Managers with limited experience in                CTA/CRAs/site personnel interested in understanding
  selecting investigator sites                                        the purpose of all the documents needed in a clinical trial
• Those looking to understand the principles that underpin the        and who need to get some practical tips in managing
  selection process to gain greater confidence in how to plan          regulatory documents
  and complete the process
                                                                      Course Overview
• Those looking to understand how the selection process
  influences site management once the study has started                • Why do we collect the CV of all study personnel within
• Those starting out who would like a forum to discuss                  a clinical trial?
  the challenges they have encountered with more                      • What documents do you need to have in place before you can
  experienced colleagues                                                start a clinical trial?
                                                                      • Why do different sponsors have apparently different
Course Overview                                                         requirements for the document package?
A significant number of issues encountered once a clinical trial       • What are the latest requirements with regards to contracts
has started (including not meeting recruitment targets) can be          and indemnities?
traced back to deficiencies at site selection – site selection is      • How do you ensure your document package is acceptable?
much more than ticking the boxes on the company required
                                                                      This computer based training course will provide the
checklist. This workshop asks you to put “first things first” and
                                                                      framework you require to gain confidence in managing
set up your trial and trial sites correctly. This workshop will be
                                                                      clinical trial documentation and provide some practical tips
relevant to anyone new to selecting investigational sites looking
                                                                      to assist you to become more effective when managing clinical
for some practical training on how to effectively plan for the
visit, organise and prioritize your time while at the site and gain   trial documentation.
confidence with the types of questions you should be asking.           Course Highlights
Course Highlights                                                     •   The purpose and value of regulatory and essential documents
By the end of this session you will be able to:                       •   Good Documentation Practices
• Outline the typical steps and phases in an effective site           •   Best practice for essential/regulatory document management
  selection including goal-setting, partnership identification and     •   Managing revisions and updates to documents
  decision making                                                     Entry Criteria
• Identify where risk may exist during the selection process and
                                                                      This is an entry level/introductory course. There are no entry
  outline various strategies to respond to these risks
                                                                      criteria for this workshop. If you have any questions on your
• Outline potential strategies to assist the management of
                                                                      suitability for this course, do not hesitate to call the ARCS
  customer relationships (both internal & external), before, during
                                                                      Business Office on (02) 8905 0829.
  & after the selection process
• Outline challenges and strategies to selecting investigator in      Type of Event: Computer based training supplemented with
  various therapeutic areas                                           case-studies and workplace examples.
                                                                      Length of Event: ½ day
Entry Criteria
To get the most out of this workshop, attendees should have           Dates
completed/assisted with several investigational site selections       Take as required – this computer based training course will be
and have questions from these experiences to discuss. The             available in 2009 via the ARCS website.
course assumes you have a good understanding of the clinical
trial process, relevant regulations and ICH-GCP. If you have any
questions on your suitability for this course, do not hesitate to
call the ARCS Business Office on (02) 8905 0829.
Type of Event: Computer based training plus workshop
Length of Event: 1 hour CBT plus ½ Day Workshop
Dates
Sydney: 19-Aug-08, 30-Mar-09
Melbourne: 13-Oct-08, 20-Apr-09




                                                        2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                    11
PROFESSIONAL DEVELOPMENT PATHWAY
FOR REGULATORY AFFAIRS PROFESSIONALS
ARCS are pleased, for the first time, to be able to provide a comprehensive professional development pathway (see Table overleaf)
for those working within regulatory affairs. This pathway has been developed by ARCS Regulatory Education Advisory Panel (REAP)
which consists of Helen Critchley (Abbott), Damien Gallagher (Genepharm), Laurence Garceau (Pharmaxis), Alexandra Park (Bayer)
Gabrijela Matanovic (Pfizer), Tony Wilson-Williams (Solvay Pharmaceuticals) and Katy King (ARCS Regulatory Affair Training Manager).
ARCS would like to acknowledge the outstanding contribution and commitment shown by these members in assisting the Association
to meet this training need for the regulatory professional. The development of these new modules outlined in the pathway have been
prioritised by REAP and we are exceptionally pleased to be delivering the first of these modules in 2008.
The suggested pathway is only a guide on how the courses on offer can assist in meeting current and future training needs. Training
needs and training solutions will be different from individual to individual and actual course selection should be done in consultation
with line management and with regards to your current and future roles and training needs. Please ensure you review all course
information available on the relevant training course before enrolling in any program.
TGA Collaboration - A New TGA/Industry Education Day
ARCS has established an ongoing collaborative relationship with regards to TGA/Industry education programs with annual TGA days
for regulatory affairs staff. In 2006 and 2007 the TGA Overview Day was held at TGA facilities – this was aimed at our new entrants
to regulatory affairs. In 2008 the TGA will be hosting a TGA Industry day - aimed at the experienced regulatory affairs members. To
supplement the TGA/Industry events there is also the annual Industry Association Update event – to provide insightful regulatory
updates from the leading Industry Associations representing the prescription medicines, medical devices and over the counter
medicines areas. See page 17 for details.
Things to look out in 2009/10 and beyond
The roll-out of new workshops and courses will continue in 2009/10 as ARCS expands its offerings for our intermediate and advanced
regulatory professionals including requirements for Pre-clinical data – Module 4 and Module 2.4 & 6, Requirements for Clinical
Data – Module 5 and Module 2.5 & 2.7, Australian Regulatory Legislation, Generic Medicines, Biotech/Biological Medicinal Product
Registration and Strategic Labelling. ARCS will also be expanding the regulatory training options to include e-learning courses.
Further updates on all of these programs, as well as registration details will be communicated via the regular ARCS Events Bulletin.
Any questions regarding the Professional Development opportunities outlined here for regulatory affairs professionals should be
directed to Katy King at katyking@arcs.com.au.



12    ARCS AUSTRALIA
                                                                      Introductory/Entry level           Intermediate           Advance/
    COURSE MODULE                                                         (up to 12 months)             (up to 3 years)      Extra Curricular
    Introduction to Regulatory Affairs (3 days)                                   ✓
    Overview of Drug Development (1 day)                                          ✓
    Drug Development and Common Technical Document
    – NEW COURSE (2 days)
                                                                                  ✓
    Requirements for Quality – Module 3 and Module 2.3
    – NEW COURSE (2 days)
                                                                                  ✓                          ✓*
    Bioavailability And Bioequivalence - Understanding and
    Applying Bioavailability and Bioequivalence (BABE)
                                                                                                              ✓                       ✓
    Guidelines – NEW COURSE (2 days)
    EU Regulatory Affairs- Pharmaceutical – NEW COURSE
    (1 day)
                                                                                                                                      ✓
    USA Regulatory Affairs- Pharmaceutical
    – NEW COURSE (1 day)
                                                                                                                                      ✓
    Clinical Statistics for Nonstatisticians (1 day)                                                          ✓                       ✓
    Advanced Clinical Statistics for Nonstatisticians (1 day)                                                                         ✓
    An Introduction to Pharmacovigilance Requirements
    (0.5 day)
                                                                                                              ✓
    Business Writing Skills (1 day)                                               ✓                           ✓                       ✓
    Advanced Business Writing (1 day)                                                                                                 ✓
    The Art of Negotiation (1 day)                                                                            ✓                       ✓
    Dealing with Difficult People (1 day)                                                                      ✓                       ✓
    Assertiveness Techniques for the Workplace (1 day)                                                        ✓                       ✓
    Personal Effectiveness (1 day)                                                                            ✓                       ✓
    The New Manager Training Program
    – NEW COURSE (2 days)
                                                                                                                                      ✓
    Fundamentals of Project Management: What Everyone
    Involved in a Project Needs to Know (1 day)
                                                                                  ✓                           ✓                       ✓
    TGA Overview Day (1 day)                                                      ✓
    TGA Industry Update Day (1 day)                                                                           ✓                       ✓
    Industry Association Update (Medicines Australia, MIAA
    & ASMI) (3 hours)
                                                                                                              ✓                       ✓
*    Refer course description.




           Why Join an Education SubCommittee (ESC) or Regional
           Networking Group (RNG)?


           • Meet people with similar professional interests              • Gain skills in networking
           • Debate ideas and “hot topics”                                • Develop skills in meeting, people and time management
           • Hear how others solve common problems                        • Have fun!
           • Contribute to the direction of ARCS education programs

           For a full list of ESCs and RNGs, visit the ARCS website or check your latest edition of the ARCS Newsletter and contact
           the Convenor today. ESCs meet approximately every 6 weeks for about 1.5 hours. Meetings are usually hosted at ARCS and
           teleconferencing facilities are provided.


                                                               2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                     13
 INTRODUCTION TO AUSTRALIAN                                             THE DRUG DEVELOPMENT
 REGULATORY AFFAIRS                                                     PROCESS AND THE COMMON
                                                                        TECHNICAL DOCUMENT
 Who Should Attend                                                      Who Should Attend
 People with no experience (or less than six months experience) in      Regulatory professionals who may be new to the industry or the
 regulatory affairs in Australia and people working in or interested    discipline, or moving into a broader role within regulatory affairs
 in regulatory affairs roles in the prescription medicines, over-the-   (e.g. from generic to innovator company).
 counter, complementary medicines or medical devices industries.
                                                                        Course Overview
 Course Overview                                                        This introductory course will provide you with practical training
 This introductory course will provide you with practical training      in how the regulatory profession fits into the overall drug
 in what regulatory affairs is all about, how therapeutic goods are     development of pharmaceuticals, and how all the information
 developed, registered and marketed and what legislative controls       gathered during development needs to be structured in CTD
 underpins such activities, and who regulates what. Learn the           format for assessment by regulators locally and worldwide.
 ‘what’, the ‘how’ and the ‘why’ of regulatory affairs.
                                                                        Please also refer to the DIA/ARCS Course – titled “Overview of
 Course Highlights                                                      Drug Development”
 Day 1
                                                                        Course Highlights
 • Regulatory Affairs as a discipline
                                                                        •   The Drug Development Process at a glance
 • Product development process
                                                                        •   The Common Technical Document (CTD) at a glance
 • Developing Ebola treatment?
                                                                        •   Early research
 • Discovery through to sale
                                                                        •   Non-clinical development
 • Role of TGA
                                                                        •   Clinical development
 • Legislation governing the supply of therapeutic goods
                                                                        •   Pharmaceutical development
   in Australia
 • Who’s who in the Therapeutic Goods Administration                    Entry Criteria
 Day 2                                                                  This is an entry level/introductory course. Attendees should have
                                                                        completed the “Introduction to Australian Regulatory Affairs”
 •   Manufacturing and GMP
                                                                        course or have equivalent experience. If you have any questions
 •   Application process, procedures, appeals
                                                                        on your suitability for this course, do not hesitate to call the
 •   Maintaining registrations
                                                                        ARCS Business Office on (02) 8905 0829.
 •   Advertising
 •   Recalls                                                            Type of Event: Workshop
 •   Access to unregistered products                                    Length of Event: 1 day
 •   Adverse drug reaction reporting
 •   Medical devices (including device classification and
                                                                        Dates
     application process and procedures)                                This course will be advertised via the regular ARCS
                                                                        communication channels. It is expected that there will be
 Day 3
                                                                        scheduled courses in both Sydney and Melbourne in 2009.
 •   GMP for medicines
 •   Applications to register prescription medicines
 •   Applications to register non – prescription medicines
 •   Labeling
 •   Product information
 •   Consumer medicine information
 Entry Criteria
 This is an entry level/introductory course. There are no entry
 criteria for this workshop. If you have any questions on your
 suitability for this course, do not hesitate to call the ARCS
 Business Office on (02) 8905 0829.
 Type of Event: Workshop
 Length of Event: 3 days
 Dates
 Sydney: 23-Jun-08, 29-Oct-08, 11-Mar-09, 24-Jun-09
 Melbourne: 08-Oct-08, 24-Mar-09




14     ARCS AUSTRALIA
                                                    PROFESSIONAL DEVELOPMENT FOR REGULATORY AFFAIRS PROFESSIONALS




REQUIREMENTS FOR QUALITY –                                           APPLYING BIOAVAILABILITY
MODULE 3 AND MODULE 2.3                                              AND BIOEQUIVALENCE (BABE)
                                                                     GUIDELINES
Who Should Attend                                                    Who Should Attend
People who have recently entered regulatory affairs experience       This session is intended for those who have some experience in
(less than twelve months experience) or who have limited             Regulatory Affairs who are seeking to broaden their knowledge
experience with Module 3: Quality and Module 2.3: QOS.               and skills in the analysis of bioavailability and bioequivalence data
Course Overview                                                      (2 years experience anticipated).
This is an introductory practical two-day course to detail the       Course Overview
requirements for Module 3: Quality and Module 2.3: Quality           An important course for those working in innovator and
Overall Summary, of a CTD format dossier (per CPMP/                  generic companies.
ICH/2887/99), including common deficiencies (as noted by the
                                                                     This is an intermediate/advanced practical session to gain an
TGA), quality variations, and the necessary data requirements.
                                                                     understanding of basic concepts of clinical pharmacology and
The 2nd day will be at the TGA in Canberra, this day will involve
                                                                     develop the ability to critically review and provide justification for
presentations and workshops with TGA PCE evaluators.
                                                                     the BABE data available.
This new course is building upon other Introductory Courses
                                                                     • Basic principles of clinical pharmacology
(Introduction to Australian Regulatory Affairs and The Drug
                                                                     • Use BABE forms in critical evaluation of BABE data
Development Process and the Common Technical Document).
                                                                     • Justify the doses used in BABE studies
At the end of the two days attendees should:                         • Provide justifications for not providing BABE studies
• Understand the data requirements of Module 3 and 2.3               • Provide justifications for chosen dosage
• Understand and appreciate the process of assembling                • Identify obvious deficiencies in validation reports
   Module 3 in consultation with the manufacturer and referring      • Understand and apply results from dissolution studies
   to the guidelines                                                 • Understand differences between EU, USA and Australian
• Understand the Module 3 review process and identify                  guidelines governing BABE
   deficiencies in consultation with the necessary guidelines         • Attendees will also be able to identify and apply guidelines
• Understand the requirements and who can sign as a Quality            governing Australian regulatory environment (with respect
   Expert for Module 2.3                                               to BABE)
• Understand the data requirements for different variations (SAN
   and Cat 3), referencing guidelines
                                                                     Course Highlights
• Identify and address the common deficiencies the TGA has            DAY 1
   noted to ensure a high quality submission                         • Basic principles of pharmacology (AUC, Tmax, Cmax) and
                                                                       statistics (confidence intervals)
Course Highlights                                                    • Advanced pharmacology concepts (single dose, steady state,
Good Manufacturing Practice                                            multiple dose), food effect, metabolic effects
  • Pre-course work                                                  • What is BA and BE; what is the difference between them?
CPMP/ICH Guideline Module 3                                          • What studies are BA studies (food not kinetics); difference
  • CTD structure                                                      between kinetic and BA study.
  • Quality Guidelines and references                                • Absolute vs relative BA. When do you need each one?
  • Module 3.2.S                                                     • When are drugs bioequivalent?
  • Module 3.2.P                                                     • EU vs USA vs Aust/NZ guidelines. Why does Australia have
  • Module 2.3                                                         different requirements?
Quality Variations
                                                                     DAY 2
• Overview of variations and ARGPM Appendix 12 & 13
                                                                     • Look at specific guidelines and at the ARGPM
TGA presentations and workshop in Canberra
                                                                     • Justification for not providing BABE
Entry Criteria                                                       • Basics of analytical validation. What is a deficient
This is an introductory course. Attendees should have attended         validation report?
“Introduction to Australian Regulatory Affairs” and/or have          • Introducing basic structure of each type of BABE report
equivalent experience and familiarisation with the basic             • Linking of formulations between clinical and validation work
requirements of Module 3: Quality and Module 2.3: QOS as             • Linking of studies to show BABE between all the formulations
defined by the guidelines. Pre-read material will be provided. If     • Dissolution testing
you have any questions on your suitability for this course, do not
                                                                     Entry Criteria
hesitate to call the ARCS Business Office on (02) 8905 0829.
                                                                     This is an intermediate/advanced course. Attendees should have
Type of Event: Workshop
                                                                     some familiarisation with ARGPM Appendix 15. If you have any
Length of Event: 2 days                                              questions on your suitability for this course, do not hesitate to
Dates                                                                call the ARCS Business Office on (02) 8905 0829.
DAY 1                                                                Type of Event: Workshop
Sydney: 04-Sep-08                                                    Length of Event: 2 days
Melbourne: 02-Sep-08                                                 Dates
DAY 2                                                                Sydney: 06-Nov-08
Canberra: 11-Sep-08                                                  Melbourne: 27-Nov-08


                                                       2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                          15
 REGULATION OF                                                        REGULATION OF
 PHARMACEUTICALS IN THE                                               PHARMACEUTICALS IN THE USA
 EUROPEAN UNION
 Who Should Attend                                                    Who Should Attend
 Regulatory affairs professionals involved in preparing global        Regulatory affairs professionals involved in preparing global
 submissions and those interacting with EU colleagues.                submissions and those interacting with USA colleagues.
 Course Overview                                                      Course Overview
 How, what and why in European Regulatory Affairs.                    An insight into USA Regulatory Affairs to help you understand
 This is an advanced session that will help you understand the        the FDA processes. This is an advanced session that will provide
 role of the key European regulatory institutions and be able to      you with an understanding of how the USA regulatory system
 outline the different regulatory procedures that operate within      operates, specifically how new drugs and biologicals
 the EU and when they are used. You will be able to describe the      are registered. The session provides information about how the
 Module 1 submission requirements for an NCE application and          FDA is structured and how sponsor companies interact with
 have an understanding of the sources of regulatory intelligence      FDA. The session will also cover new topics of interest such
 that may assist with developing regulatory strategy for the EU.      as eCTD, paediatric regulation and risk management and
 Course Highlights                                                    how these global hot topics are potentially impacting the US
                                                                      regulatory environment.
 • Who’s who in the EU
 • Legislative framework                                              Course Highlights
 • Registering an NCE                                                 •   History of drug regulation in the USA
 • Registration process (Centralised Procedure                        •   The basis of regulatory affairs in the USA
   and Decentralised)                                                 •   Overview of FDA
 • Mutual recognition procedures for existing products                •   The IND
 • Regulatory intelligence                                            •   The NDA and BLA
 • Life cycle management                                              •   The ANDA and SNDA
 Entry Criteria                                                       •   Communicating with FDA
 This is an Advanced course for those with 3 years experience         •   Pharmacovigilance
 in regulatory affairs or with a particular need to understand        •   Labeling and advertising
 the EU system. Understanding of CTD, drug development/               •   Hot topics
 clinical development is assumed. If you have any questions on        Entry Criteria
 your suitability for this course, do not hesitate to call the ARCS
                                                                      This is an advanced course for those with more than three
 Business Office on (02) 8905 0829.
                                                                      years experience in regulatory affairs or with a particular need to
 Type of Event: Workshop                                              understand the US FDA system. Understanding of CTD, drug
 Length of Event: 1 day                                               development/clinical development is assumed. If you have any
 Dates                                                                questions on your suitability for this course, do not hesitate to
                                                                      call the ARCS Business Office on (02) 8905 0829.
 This course will be advertised via the regular ARCS
 communication channels. It is expected that there will be            Type of Event: Workshop
 scheduled courses in both Sydney and Melbourne in 2009.              Length of Event: 1 day
                                                                      Dates
                                                                      Sydney: 30-Sep-08
                                                                      Melbourne: 02-Oct-08




16   ARCS AUSTRALIA
OTHER PROFESSIONAL DEVELOPMENT OPPORTUNITIES FOR
REGULATORY AFFAIRS PROFESSIONALS

TGA OVERVIEW DAY                                                   TGA/INDUSTRY UPDATE DAY


Who Should Attend                                                  Who Should Attend
New regulatory affairs professionals                               Experienced regulatory affairs professionals
Course Overview                                                    Course Overview
ARCS and the TGA have been working closely together to             ARCS and the TGA have been working closely together to
deliver the TGA Overview Day. This event has proven to be          organise an additional more senior Government Industry event.
very popular event and is held at the TGA site in Symonston,       The “TGA – Industry Update Day” is intended to provide
Canberra. This day is intended to provide new Regulatory           experienced regulatory affairs professionals an update on “hot
Affairs professionals with an introduction and exposure to the     topics” for prescription medicines and exposure to the TGA,
TGA as well as grounding in the various listing and registration   Drug Safety and Evaluation Branch. The ARCS Regulatory
procedures. TGA staff from various branches review the key         Education Sub-Committee plays a key role in developing the
factors impacting on quality of submissions to TGA. TGA staff      session topic for this TGA Industry Update day. This event will be
are available during breaks for informal discussions and tours     held at the TGA site in Symonston, Canberra. The TGA staff are
of the TGA Laboratories and facilities are conducted. It is the    invited to be available during breaks for formal discussion.
intention of ARCS and the TGA to hold this event every two
years alternating with the TGA/Industry Update Day (see below).    Proposed Program Highlights
Course Highlights                                                  The topics are subject to TGA confirmation.
• Optional tour of TGAL (dependent on TGA staff availability       •   Electronic submissions
  and OH&S)                                                        •   Quality topics - DMF/CEP & TSE
• Overview of GMP Requirements for Therapeutic Goods               •   Preclinical topics
• Overview of Prescription Medicines and Quality                   •   Clinical Topics - PI negotiations
  data submissions                                                 Type of Event: Conference
• Overview of OTC Medicines and submissions                        Length of Event: 1 day
• Overview of Complementary Medicines and submissions
• Overview of Therapeutic Devices and submissions                  Dates
• Overview of Preclinical & Clinical Data for                      This course will be advertised via the regular ARCS
  prescription medicines                                           communication channels. It is expected that this will be
Type of Event: Conference                                          scheduled in Canberra - October 2009.
Length of Event: 1 day
Dates                                                              INDUSTRY ASSOCIATIONS
Canberra: Oct/Nov 2009 (actual date and agenda yet                 ANNUAL UPDATE
to be finalized)


                                                                   Who Should Attend
                                                                   This seminar is aimed at experienced Regulatory
                                                                   Affairs professionals seeking updates from the various
                                                                   Industry Associations.
                                                                   Course Overview
                                                                   This is a regular annual seminar which includes updates
                                                                   on important industry policy issues from three key industry
                                                                   associations - Medicines Australia (MA), Australian Self
                                                                   Medicating Industry (ASMI) and Medical Technology Association
                                                                   of Australia (MTAA) representing the Prescription Medicines,
                                                                   OTC and Complementary Medicines and the Medical Devices
                                                                   and Diagnostics industries respectively. ARCS are planning to
                                                                   expand the Industry Association representation over time.
                                                                   Type of Event: Seminar
                                                                   Length of Event: 3 hours
                                                                   Dates
                                                                   Sydney: Feb-09
                                                                   Melbourne: Feb-09
                                                                   Actual date and agenda yet to be finalized



                                                     2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                   17
             ARCS In-company Training
             Now Available!
             Deliver the industry’s best training courses to your employees or coworkers at your
             company location.

             •   Taught by ARCS selected facilitators who are professionals in the pharmaceutical and
                 related industries and are highly practiced and experienced in their particular discipline(s)
             •   Very cost effective for companies requiring training for 8 to 16 learners
             •   Attendees must be either employed by or contracted to work with the same company
                      or institution
             •   Courses can be adapted to fit company needs
             •   Costs are all inclusive: ARCS provides the instructor(s) and all learning materials
             •   Company provides students, audiovisual equipment, catering (if applicable) and
                 learning-friendly environment

             For a complete list of ARCS training courses that can be delivered to your employees at your
             company location, contact Joe Badolato, (02) 8905 0829 or email joebadolato@arcs.com.au




             www.arcs.com.au
18   ARCS AUSTRALIA
PROFESSIONAL DEVELOPMENT FOR HEALTH ECONOMISTS



AN INTRODUCTION FOR                                                          A PRACTICAL UPDATE ON THE
THE PROCESS OF LISTING A                                                     PBAC SUBMISSION GUIDELINES
MEDICINE ON THE AUSTRALIAN
PHARMACEUTICAL BENEFITS
                                                                             Who Should Attend
SCHEME (PBS)                                                                 This workshop will be invaluable for all those involved in the
                                                                             preparation and submission of applications to the PBAC. This
Who Should Attend                                                            seminar will assist attendees become fully conversant with the
This seminar is intended to provide new industry professionals               finer detail of the guidelines.
or those sales, marketing and management positions with an                   Course Overview
interest in health economics an introduction to the PEB as well              ARCS in association with the Department of Health and Ageing,
as grounding in the listing and pricing procedures. Government               Pharmaceutical Benefits Division (PBD) will be running a repeat
staff from within the Pharmaceutical Evaluation Branch and the               of the popular one day industry education workshop to provide
Pricing Section present on the roles of branches, sections and               an opportunity for industry to work through realistic hypothetical
sub-committees within the PEB and staff are available during                 examples to provide familiarisation with version 4.2 of the
breaks for informal discussions.                                             guidelines for preparing submissions to the PBAC.
Course Overview                                                              Senior evaluators from the PEB will lead the discussions, and
This has become a popular annual seminar held in Canberra.                   will be supported by representatives from industry experienced
The ARCS Health Economics Education Sub-Committee and                        in preparing submissions and staff of PBD who manage the
the PEB review and develop the program on an annual basis.                   evaluation process to facilitate discussions and group work.
                                                                             Invitations have also been extended to a number of evaluators
Program Highlights                                                           to provide the broadest possible range of expertise available on
•   Overview of the PEB                                                      the day.
•   Overview of PBS
•   Introduction to PBAC and it’s sub-committees                             Program Highlights
•   Overview of the role of PBPA and pricing section                         • Update on changes to the Guidelines
                                                                             • Realistic hypothetical examples
Entry Criteria                                                               • Feedback on submissions written to the new guidelines
There are no entry criteria for this seminar. If you have any
questions on your suitability for this course, do not hesitate to            Entry Criteria
call the ARCS Business Office on (02) 8905 0829.                              There are no entry criteria for this workshop. If you have any
Type of Event: Seminar                                                       questions on your suitability for this course, do not hesitate
                                                                             to call the ARCS Business Office on (02) 8905 0829.
Length of Event: 1 day
                                                                             Type of Event: Workshop
Date                                                                         Length of Event: 1 day
Canberra: Dec-08
                                                                             Date
                                                                             Sydney: Date TBC




         DIA eMembership
         - 50% Discount Off Standard Membership



         Drug Information Association (DIA) is the premier, member-driven, not-for-profit association in
         the pharmaceutical and related healthcare industries. DIA is proud to offer ARCS members 50%
         discount off Standard Membership by offering eMembership at a cost of US$65.00. Members with
         an eMembership receive DIA publications electronically, rather than in hard copy. eMembership
         gives you access to a wide variety of activities and resources, including full access to members-
         only areas of the DIA website.




                                                         2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                             19
                      1 - 3 JUNE
                                         2009
                      18TH ANNUAL SCIENTIFIC CONGRESS




           Professional Development
           for the Therapeutics Industry™




 Sydney Convention & Exhibition Centre
20   ARCS AUSTRALIA
PROFESSIONAL DEVELOPMENT FOR DRUG SAFETY/
PHARMACOVIGILANCE PROFESSIONALS

INTRODUCTION TO                                                       A PRACTICAL COURSE FOR
PHARMACOVIGILANCE                                                     PHARMACOVIGILANCE
REQUIREMENTS                                                          PROFESSIONALS
Who Should Attend                                                     Who Should Attend
Professionals who are new to the pharmaceutical industry and          This is an intermediate course intended for practicing drug
need to understand the role of pharmacovigilance within the           safety associates.
drug development process. It is anticipated that individuals from
a variety of educational areas including, drug safety, regulatory     Course Overview
affairs, medical information, quality assurance, and clinical         We remember 10% of what we read, 50% of what we see and
research will benefit from attending this workshop.                    hear, and 90% of what we say and do. This workshop seeks
                                                                      to build on the topics covered during the first module titled
Course Overview
                                                                      “Introduction to Pharmacovigilance Requirements” by helping
When Hippocrates in 500BC stated “PRIMUM NON NOCERE”
                                                                      attendees apply what they’ve learned through the formulation of
or “First, do no harm” he could not have envisaged the central
                                                                      an individual case source report (ICSR).
role that pharmacovigilance would have in assisting physicians
meet this cornerstone of medicine. This workshop will provide         Attendees will learn to code verbatim terms into preferred terms
attendee’s with an understanding of the importance of the role        using MedDra coding conventions, followed by writing a narrative
of pharmacovigilance in the drug development process and life         report with reporter causality, and the entry of relevant laboratory
cycle of a therapeutic good.                                          data/diagnostic findings, concomitant medications to assist with
                                                                      medical assessment.
Course Highlights
By the end of this session participants should be able to:            After the completion of each ICSR, attendees will be shown how
                                                                      to correctly determine the appropriate assessment for reporting
• Describe the purpose and rational for pharmacovigilance
                                                                      to local regulatory reporting requirements. In addition, the
  during the life cycle of a therapeutic good
                                                                      attendee will learn to write a follow-up letter requesting missing
• Outline how adverse events are defined
                                                                      information to complete a ICSR on the CIOMS format.
• Explain the difference between the concepts of causality,
  seriousness and expectedness                                        Course Highlights
• Identify the local regulations and reporting requirements for       By the end of this session you should be able to:
  adverse events                                                      1. Complete a CIOMS safety report
• List various report sources for Adverse Events (including           2. Describe minimum information needed from reporters.
  literature and foreign)                                             3. Clarify how Adverse Events are coded
Although this module will focus on pharmaceuticals, differences       5. Understand the differences in structured terminology.
in reporting for medical devices, biologicals, and vaccines will be   6. Identify the reporting obligations/timelines for marketed and
highlighted throughout the session.                                      investigational products
Entry Criteria                                                        Although this module will focus on pharmaceuticals, differences
This is an entry level/introductory course. There are no entry        in reporting for medical devices, biologicals, and vaccines will be
criteria for this workshop. If you have any questions on your         highlighted throughout the session.
suitability for this course, do not hesitate to call the ARCS         Entry Criteria
Business Office on (02) 8905 0829.
                                                                      Attendee should have completed “Introduction to
Type of Event: Workshop                                               Pharmacovigilance Requirements” or have equivalent knowledge
Length of Event: 0.5 day                                              covered in the training course. If you have any questions on
                                                                      your suitability for this course, do not hesitate to call the ARCS
Dates
                                                                      Business Office on (02) 8905 0829.
This course will be advertised via the regular ARCS
communication channels. It is expected that there will be             Type of Event: Workshop
scheduled courses in both Sydney and Melbourne in 2009.               Length of Event: 1 day
                                                                      Dates
                                                                      This course will be advertised via the regular ARCS
                                                                      communication channels. It is expected that there will be
                                                                      scheduled courses in both Sydney and Melbourne in 2009.




                                                       2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                         21
ARCS / DIA PARTNERSHIP COURSES
The content of the following six (6) workshops has been derived from material prepared by DIA and has been exclusively
licensed to ARCS Australia for presentation in Australia and New Zealand. ARCS is proud to present these courses with the
assistance of our network of experienced Australian facilitators and with modifications designed to ensure their relevance to
the Australian environment.




  OVERVIEW OF                                                           PRACTICAL CONSIDERATIONS IN
  DRUG DEVELOPMENT                                                      DRUG DEVELOPMENT

  Who Should Attend                                                     Who Should Attend
  This course is a “survey” course rather than a “how-to” course.       • Therapeutics industry professionals, including those working
  It is intended to describe the “big picture” for personnel seeking      in clinical operations and allied fields such as regulatory
  to gain a better understanding of how their roles fit into the           affairs, data management, project management, and medical
  overall process of pharmaceutical development. It is especially         writing that need to clearly understand their role and the role
  helpful for administrative staff and those from most disciplines        of others with whom they interact to help facilitate the drug
  who have limited tenure or breadth of experience in the                 development process
  pharmaceutical industry. Although some specific developmental          • Those leading development programs from or within Australia
  procedures will be reviewed, along with applicable regulations          (including those working in biotechs or smaller start up
  and guidelines, the course provides broad-brush descriptions            companies) needing a deeper understanding of the drug
  without in-depth discussion.                                            development process
                                                                        • Investigational site personnel (in particular investigators)
  Course Overview                                                         contributing to development programs would also benefit from
  This course provides an overview of how new pharmaceutical              this course
  products are identified and developed. The roles and
                                                                        Course Overview
  interactions among marketing, clinical R&D, regulatory affairs,
  and manufacturing will be reviewed. A basic description of the        With the drug development process becoming increasingly more
  Australian regulatory framework will lead to a review of how          competitive, complex and global, it is necessary for product
                                                                        development professionals to clearly understand their role and
  clinical trials are started, completed and reported as well as
                                                                        the role of others with whom they interact, to help facilitate a
  ethical considerations in conducting clinical research. The course
                                                                        drug development process that is both timely and completed
  material focuses on developing drugs and biologics under
                                                                        within budget. This course will provide enhance the knowledge
  Australian regulations and ICH-GCP guidelines.
                                                                        and skill set needed to improve the drug development process.
  Course Highlights                                                     Course Highlights
  • At the conclusion of this course, participants should be able to:   At the conclusion of this course, participants should be able to:
  • Recognise the process of discovering and developing new             • Discuss the product development process and identify some
    pharmaceutical products                                               challenges facing the industry in today’s environment
  • Describe the activities associated with conducting clinical         • Apply clinical research planning principles
    research and reporting the results and responsibilities of          • Outline the processes for protocol development, case report
    various departments in accomplishing these activities                 form design, and preparation of integrated study reports
  • Understand the ethical considerations underpinning                  • Discuss ethical principles of clinical research and
    clinical studies                                                      applicable regulations
  • Develop knowledge about concepts and functions associated           • Discuss current practices and challenges in clinical
    with ensuring overall quality of studies                              trials management
  • Describe the organisation of the Australian regulatory authority,   • Demonstrate knowledge about concepts and functions
    their requirements and interactions with sponsor companies            associated with ensuring overall quality of studies
  Entry Criteria                                                        Entry Criteria
  There is no entry criteria for this workshop. If you have any         There are no entry criteria for this workshop, however attendee
  questions on your suitability for this course, do not hesitate to     should have some understanding of Australian regulatory
  call the ARCS Business Office.                                         environment and GCP principles. If you have any questions on
  Type of Event: Workshop                                               your suitability for this course, do not hesitate to call the ARCS
                                                                        Business Office on (02) 8905 0829.
  Length of Event: 1 day
                                                                        Type of Event: Workshop
  Dates                                                                 Length of Event: 3 days
  Sydney: 17-Jun-08, 09-Sep-08, 25-Feb-09, 22-Jun-09
                                                                        Date
  Melbourne: 01-Nov-08, 15-Jun-09                                       This course will be advertised via the regular ARCS
  Brisbane: 27-Jun-08                                                   communication channels. It is expected that there will be
                                                                        scheduled courses in both Sydney and Melbourne in 2009.




22     ARCS AUSTRALIA
                                                                                                ARCS / DIA PARTNERSHIP COURSES




FUNDAMENTALS OF PROJECT                                                PROJECT MANAGEMENT
MANAGEMENT: WHAT EVERYONE
INVOLVED IN A PROJECT NEEDS
TO KNOW                                                                Who Should Attend
                                                                       • Professionals leading clinical development projects for example,
Who Should Attend                                                        preclinical through to those working in local phase IV market
                                                                         driven studies, or those leading clinical projects from Australia for
This course will be of interest to project team members from all         both the Australian and International market(s)
the ARCS educational areas and individuals who are team leads          • Regulatory managers or regulatory project leaders tracking
or functional employees from areas such as clinical, regulatory          global and local development plans looking to establish PM tools
from the biotech/pharmaceutical industry, as well other industry         for themselves
                                                                       • Professionals from any ARCS educational areas looking to
professionals, who do not have the title of Project Manager,             understand how to build and manage a project plan and
but who want to gain an understanding of project management              schedule from first principles
processes. It is intended for Biotech/pharmaceutical                   • Those looking to get a deeper understanding of project
professionals looking to gain an awareness of the basic project          management processes especially those working for CROs,
                                                                         generic and biotech companies
management processes.
                                                                       Course Overview
Course Overview                                                        This course is intended for project managers and other biotech/
With or without the title of Project Manager, most people today        pharmaceutical industry professionals having responsibility for
                                                                       the management or leadership of projects. You will learn the
are involved in project work. But for the majority of us, using        fundamentals of project management and how they can be applied
formalised project management is like hiring an accounting firm         to best meet the needs of projects.
to balance our cheque book accounts. And yet, when used                Participants are encouraged to bring real-life case studies to the
intelligently, project management principles and techniques can        forum for discussion, and mutual learning.
be invaluable for the “nonproject management professional.”            At the conclusion of this course, participants should be able to:
This one-day workshop is intended for biotech/pharmaceutical           • Describe the project management process - initiating, planning,
industry professionals who need an awareness of the basic                 executing, controlling and closing the project and best practices
                                                                       • Recognise project management tools and techniques
project management processes.
                                                                       • Apply these tools and techniques to the part of the drug
At the conclusion of this course, participants should be able to:         development process that you are engaged in within
• Decide when work effort should be treated as a project                  your organisation
                                                                       • Discuss sensitivities to working within a matrixed, project team
• Use the four-step model to manage projects
• Apply motivational and team building techniques to gain              Course Highlights
  support and buy-in                                                   • Introduction
                                                                       • Initiating
• Employ practical leadership and communication skills to                 • Scope, Cost, Time, Quality, Risk (first look)
  ensure coordination and collaboration during the project                • Master Project Plan
                                                                       • Planning
Course Highlights                                                         • Assemble the team, establish objectives
Module 1: Clarify – Step 1: To make clear or become clear                 • Network diagrams, Gantt charts
                                                                          • Best practice planning
Module 2: Coordinate – Step 2: To harmonise in a                          • Communication plan
common action                                                             • Plan and balance the work
                                                                       • Executing and Controlling
Module 3: Collaborate – Step 3: To work together                          • Process and reports
Module 4: Close – Step 4: To end; finish                                   • Change control
                                                                       • Risk Management (detail)
Module 5: Prioritising multiple projects                                  • Identify, analyse, plan and track risks
                                                                       • Team dynamics
Entry Criteria                                                            • Teams, motivation, integration
There are no entry criteria for this workshop. If you have any         • Project Closing
questions on your suitability for this course, do not hesitate to      During the course, in workshops and break-out sessions with other
                                                                       participants, you will have opportunity to develop a project plan
call the ARCS Business Office on (02) 8905-0829.                        from first principles, identify critical elements in the project, and
Type of Event: Workshop                                                learn from the experience of others.
Length of Event: 1 day                                                 Entry Criteria
                                                                       There are no entry criteria for this workshop. If you have any
Dates                                                                  questions on your suitability for this course, do not hesitate to call
                                                                       the ARCS Business Office on (02) 8905 0829.
Sydney: 14-Aug-08, 12-Dec-08, 08-Apr-09
                                                                       Type of Event: Workshop
Melbourne: 03-Dec-08, 16-Jun-09                                        Length of Event: 3 days
                                                                       Dates
                                                                       Sydney: 10-Sep-08, 06-May-09
                                                                       Melbourne: 03-Dec-08
                                                                       Brisbane: 24-Jun-08




                                                        2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                       23
    CLINICAL STATISTICS                                                    ADVANCED CLINICAL STATISTICS
    FOR NONSTATISTICIANS                                                   FOR NONSTATISTICIANS

    Who Should Attend                                                      Who Should Attend
    Biotech/pharmaceutical industry professionals who need                 Attendees should have a basic understanding of statistics, or
    to understand and work with statistical concepts related to            have taken “Clinical Statistics for Nonstatisticians” training
    clinical research.                                                     course. Additionally, this course will benefit therapeutics industry
                                                                           professionals who seek to understand, at an advanced level, the
    Course Overview                                                        impact of statistics on clinical research.
    This course is designed to be an introduction of basic statistical
    concepts fundamental to clinical research, for professionals           Course Overview
    who have regular exposure to statistics either through studies or      Designed as a follow-up to the existing ARCS/DIA training
    professional experience. The material is roughly equivalent to an      course, “Clinical Statistics for Nonstatisticians,” this course,
    introductory statistics course. While it includes a few formulae       focuses on answering common questions and addressing topics
    for individuals who are interested in computational details, the       such as modeling, multiplicity adjustments, non-inferiority, PK/
    course emphasizes the application of statistical concepts to           PD, data mining, adaptive designs, Bayesian principles, survival
    clinical investigation.                                                methods, etc., that have been raised by participants in the first
                                                                           course over the past several years. While the material in the
    At the conclusion of this course, participants should be able to:
                                                                           advanced course is certainly more technically complex, the
    • Discuss basic statistical concepts such as variability,
                                                                           presentation of this material will aim to achieve the same general
      confidence intervals, hypotheses testing, and P-values
                                                                           goal as the first course – to increase the level of statistical
    • Distinguish various study designs and identify techniques
                                                                           knowledge of nonstatisticians so that collaborative efforts of
      to avoid bias
                                                                           statisticians and nonstatisticians on clinical investigative teams
    • Design a study with decreased variability and
                                                                           can be improved.
      increased precision
    • Demonstrate how to establish clinical equivalence                    Course Highlights
    • Use basic statistical terminology with ease                          •   Statistics modeling
    • Discuss the statistician’s role in clinical research                 •   Bayesian principles and adaptive designs
    Key Topic: Basic statistical principles pertinent to                   •   Multiplicity adjustments: why, when, and how
    clinical research                                                      •   Data mining
                                                                           •   Survival Analysis
    Course Highlights                                                      •   Design and analysis of equivalence/non-inferiority trials
    Day 1
                                                                           At the conclusion of this course, participants should be able to:
•       Basic statistical concepts
                                                                           • Use statistics to make better decisions in the drug
•       Hypothesis testing                                                   development process
•       Study designs                                                      • Describe what a statistical model does and what it cannot do
•       Analysis plan                                                      • Recognize why multiplicity adjustments may be necessary and
    Day 2:                                                                   identify the pros and cons of these adjustment methods
                                                                           • Design clinical equivalent and non-inferiority clinical trials
    •   Survival analysis
                                                                           • Discuss fundamental statistical concepts concerning PK/PD
    •   A trial for superiority
                                                                             such as bioequivalence
    •   A trial for equivalence
                                                                           • Discuss some preliminary issues surrounding the bases of
    •   Meta analysis
                                                                             Bayesian analyses
    Entry Criteria                                                         • Describe how survival analyses can be adapted
    There are no entry criteria for this workshop. It assumes a
                                                                           Entry Criteria
    basic understanding of statistics (either through professional
                                                                           There are no entry criteria for this workshop. It assumes a
    experience or studies) roughly equivalent to an introductory
                                                                           basic understanding of statistics (either through professional
    statistics course. If you have any questions on your suitability for
                                                                           experience or studies) roughly equivalent to an introductory
    this course, do not hesitate to call the ARCS Business Office.
                                                                           statistics course. If you have any questions on your suitability for
    Type of Event: Workshop                                                this course, do not hesitate to call the ARCS Business Office.
    Length of Event: 2 days                                                Type of Event: Workshop
    Dates                                                                  Length of Event: 2 days
    Sydney: 27-Oct-08, 06-Apr-09
                                                                           Dates
    Melbourne: 07-May-09                                                   Sydney: 16-Feb-09




24         ARCS AUSTRALIA
NON-TECHNICAL PROFESSIONAL DEVELOPMENT TRAINING



MANAGING AND RESOLVING                                                ASSERTIVENESS TECHNIQUES
CONFLICT IN THE WORKPLACE                                             FOR THE WORKPLACE

Who Should Attend                                                     Who Should Attend
Team leaders, supervisors, managers and employees who                 Team leaders, supervisors, managers and employees who wish
needs to be able to manage and resolve conflict positively             to make choices without feeling guilty, and where you are in
and in a professional manner within various research teams            control, not those around you. Learn appropriate skills to be more
and/or departments.                                                   assertive with the internal and external members of your research
                                                                      teams/departments.
Course Overview
                                                                      Course Overview
This program is designed to enhance your conflict resolution
skills by exploring what conflict is and how conflict affects           This workshop has been designed to give participants the
                                                                      knowledge and skills required to recognise their responses in
people. You will look at the positive and negative aspects
                                                                      challenging situations, and how to develop effective responses,
of conflict, and identify the most effective approach to
                                                                      and express their thoughts, needs and ideas more confidently
managing conflicts.
                                                                      and assertively.
On completion of this program you should be able to:                  On completion of this program you should be able to:
• Recognise the difference between functional and                     • Understand what assertiveness is and the advantages it has
  dysfunctional conflict                                                 compared to submissive and aggressive behaviour
• Recognise the early signs of conflict arising and how to             • Recognise and apply three important principles of
  avoid escalation                                                      assertive behaviour:
• Identify the different levels of conflict                              • Being honest about what is relevant
• Select the appropriate conflict management styles                      • Sticking to the bottom line – How to say “No”
• Analyse the needs of each party in a dispute                          • Negotiating as equals
• Overcome the barriers to effective communication experienced        • Improve your self-esteem and confidence
  in conflict                                                          • Become more assertive in your personal and professional life
• Develop skills to resolve conflict in a flexible manner               • Command more respect from your peers, subordinates
“It was the first training our employees had done in a long time         and managers
and a course that required the employees to be open and               “Thank you for the recent training. I found the program enjoyable,
honest. Jan gained an immediate rapport, where people felt            confronting, challenging and very beneficial. I was able to take
comfortable to interact and share their challenges and concerns       away a number of ideas from each course to put into practice
openly. The staff loved the course and Jan!”                          whether it be at work or home.”
Course Highlights                                                     Course Highlights
• What is conflict?; Good v. Bad conflict; identifying levels           •   Assertiveness: what is it and why it matters
  of conflict                                                          •   Aggressive v. Submissive v. Assertiveness
• The key skills; appropriate conflict management style; defining       •   The assertiveness quiz
  and mapping the conflict                                             •   Learning to be assertive
• Barriers to effective communication                                 •   Recognising non-assertive behaviour
• Improving active listening skills                                   •   Power bases
• What does your body say?                                            •   Manipulation v. Influencing
• Checking for understanding                                          •   The games people play
• Being empathetic                                                    •   Your personal bill of rights
• Case studies and skills development                                 •   Developing “I” statements
• Personal action plan                                                •   Video ‘straight talking’
                                                                      •   Honesty is the best policy
Entry Criteria                                                        •   How to give feedback
There are no entry criteria for this workshop. If you have any        •   Sticking to the bottom line
questions on your suitability for this course, do not hesitate to     •   Negotiating as equals
call the ARCS Business Office on (02) 8905 0829.                       •   Personal action plan
Type of Event: Workshop                                               Entry Criteria
Length of Event: 1 day                                                There are no entry criteria for this workshop. If you have any
                                                                      questions on your suitability for this course, do not hesitate to
Dates
                                                                      call the ARCS Business Office on (02) 8905 0829.
Sydney: 23-Oct-08, 23-Mar-09
                                                                      Type of Event: Workshop
Melbourne: 29-Apr-09
                                                                      Length of Event: 1 day
                                                                      Dates
                                                                      Sydney: 24-Oct-08, 24-Mar-09
                                                                      Melbourne: 30-Apr-09

                                                        2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                       25
 DEALING WITH DIFFICULT PEOPLE                                          THE ART OF NEGOTIATION


 Who Should Attend                                                      Who Should Attend
 Managers, supervisors, team leaders and employees who want             Team leaders, supervisors, managers and employees who wish
 to learn how to diffuse negative situations, cope effectively with     to negotiate win/win outcomes in a positive, assertive manner.
 dissenting internal and external research team members and             Learn how negotiation skills can assist with improving outcomes
 manage obstructive, difficult behavior.                                 in your next budget/contract agreement or in your next encounter
 Course Overview                                                        with a government agency.
 What’s the matter with people anyway? Why can they be so               Course Overview
 difficult to get along with? In this fast-paced, fun filled program,     Successful people use their negotiation skills to build stronger,
 Jan Burnes shows you that most people are more different than          more profitable relationships with their clients, work colleagues
 they are difficult, and that they don’t intentionally set out to make
                                                                        and family members. It can be a valuable opportunity to
 your life miserable! She identifies all the different people you
                                                                        demonstrate trust, respect and a sound understanding of the
 work with and live with, and then shows you exactly how
 to motivate them and get results with them, even the truly             other person’s needs. Poor negotiation can sour relationships,
 difficult ones.                                                         resulting in deals that neither party are entirely satisfied with.
                                                                        This one-day module covers the basics of negotiation, from
 On completion of this program, you will learn how to:
                                                                        preparation to closing the deal, and is suitable for novices and
 • Recognise and appreciate diversity and it’s value in
                                                                        seasoned negotiators alike.
   the workplace
 • Communicate effectively with different behavioural styles            On completion of this program you should be able to:
 • Get the cooperation and results you need without                     • Recognise your natural negotiation style
   damaging relationships                                               • Identify opportunities for negotiation more readily
 • Defuse even the most volatile situation                              • Prepare thoroughly prior to any negotiation
 • Discuss problems without causing defensive reactions                 • Work out and stay within your ‘bottom line’
 • Handle upset or angry colleagues and customers                       • Enter confidently into negotiation with a win/win philosophy
 • Control your own anxieties and fears while confronting               • Close the negotiation
   difficult people
                                                                        “I thought I would drop you a line as I had a very successful
 • Manage your stress levels
                                                                        negotiation last night in relation to the problems I was having
 “Thank you for an excellent course and being such a wonderful          at my local sports club. Thoughtfully and naturally the skills I
 presenter Jan. I gained a lot from the one day and have been
                                                                        learned from your program came out, and I was able to get what I
 implementing many tips. My children have been two of my
                                                                        needed while keeping everyone else happy and on side. Great to
 unwitting targets, plus a few people at work… which has greatly
 reduced my stress!”                                                    have such immediate results – a great workshop.”

 Course Highlights                                                      Course Highlights
 •   What’s the matter with people anyway?                              •   Defining negotiation
 •   Listen up!                                                         •   Assessing your ability
 •   The nice, the difficult, the wimp                                   •   Understanding the principals of exchange
 •   The four behavioral styles                                         •   Identifying objectives
 •   Bridging the generational gap.                                     •   Deciding on your BATNA and WATNA
 •   Leaders love rainbows - multi-cultural teams                       •   Assessing the other party
 •   Gender-flex – learn the language!                                   •   Finding common ground
 •   Communicating with difficult people                                 •   Judging the mood
 •   Giving constructive feedback constructively!                       •   Making a proposal
 •   How to disagree respectfully                                       •   Making concessions
 •   Handling upset and angry people                                    •   Making hypothetical proposals
 •   Dealing with your own anger and frustration                        •   Choosing how to close
 •   Is it possible that I’m the difficult person?                       •   Closing the deal
 •   Ready, set, go! Action plan
                                                                        Entry Criteria
 Entry Criteria
                                                                        There are no entry criteria for this workshop. If you have any
 There are no entry criteria for this workshop. If you have any
                                                                        questions on your suitability for this course, do not hesitate to
 questions on your suitability for this course, do not hesitate to
                                                                        call the ARCS Business Office on (02) 8905 0829.
 call the ARCS Business Office on (02) 8905 0829.
 Type of Event: Workshop                                                Type of Event: Workshop

 Length of Event: 1 day                                                 Length of Event: 1 day

 Dates                                                                  Dates
 Sydney: 24-Nov-08, 25-Mar-09                                           Sydney: 25-Nov-08, 31-Mar-09
 Melbourne: 01-May-09                                                   Melbourne: 05-May-09

26     ARCS AUSTRALIA
                                                                     NON-TECHNICAL PROFESSIONAL DEVELOPMENT TRAINING




INCREASING YOUR EFFECTIVENESS                                          THE NEW MANAGER
AT WORK                                                                TRAINING PROGRAM

Who Should Attend                                                      Who Should Attend
Team leaders, supervisors, managers and employees who wish to          • Those who have recently become a manager and looking to
improve their productivity whilst reducing their work load, reduce       understand your new responsibilities.
their stress levels and have a greater sense of achievement and        • Those with some experience as a manager looking to develop
life/work balance.                                                       new approaches and ideas.
                                                                       • Those looking to get some reinforcement on your current
Course Overview
                                                                         efforts to become even more an effective manager.
Are You...(1) Feeling challenged by not having enough hours
in the day? (2) Interested in efficiency, balance, and a fulfilling      Course Overview
life? (3) Feeling your days are spent forever ‘putting out fires’       Congratulations on your new position as a manager. If this is
(4) Exhausted at the end of the day? (5) Lying awake worrying          your first opportunity to supervise the activity of others, you’re
about all you have to do tomorrow? Then attend our one-day             possibly looking forward to the experience. For many, however,
‘Personal Effectiveness’ program, where you will learn practical,      supervising others brings a mix of anticipation and fear. There is
proven techniques to prioritise your time, increase your personal      the promotion to the new position itself, the opportunity to teach
productivity, regain a feeling of control, and do away with            others and share your knowledge, and a new sense of authority
unnecessary tasks. Oh, and incidentally, you will reduce those         and control. There is also the fear of having to depend on
killer stress levels too!                                              others to do the work, of getting their respect and attention – of
On completion of this program you should be able to:                   being responsible for what others do. You’ll find that there is no
• Achieve a more balanced life style                                   magic to being a good or even a great supervisor. It takes some
• Prioritise your time for more effective outcomes                     understanding of human behaviour combined with the timely
• Eliminate time wasters                                               application of effective management skills.
• Set and achieve meaningful goals                                     After attending this workshop you will:
• Reduce your current stress levels                                    • Have a clear understanding of the role and responsibilities
                                                                         of the Manager
Course Highlights
                                                                       • Use communication skills to develop trust and rapport
• Realising the value of our time                                      • Recognise the characteristics of a high performing team
• Personal effectiveness equals self management                        • Know how to motivate and encourage employees
• Strategies for dealing with productivity pirates                     • Learn how and when to give effective feedback
• Identifying your life values                                         • Use a decision planner to evaluate likely results of a decision
• Goal setting                                                         • Identify major time wasters and prioritise their work load
• The golden rules for good time management                            • Know which tasks to delegate and how
• Managing priorities - time-value matrix                              • Manage negative situations
• Delegation                                                           • Guide their team through the stages of team development
• Dealing with procrastination                                         • Know when to coach and when to be a mentor
• Controlling the telephone
• Handling visitors                                                    Course Highlights
• Managing meetings                                                    •   The role of the manager
• Behavioural styles and their approach to time                        •   The manager as a leader
  management issues                                                    •   Establishing and maintaining relationships
• Self management strategies to reduce stress                          •   Developing your people
• Your personal action plan                                            •   Managing individual and team performance
                                                                       •   Legal matters
Entry Criteria
                                                                       •   Self management
There are no entry criteria for this workshop. If you have any         •   Personal development plan
questions on your suitability for this course, do not hesitate to
call the ARCS Business Office on (02) 8905 0829.                        Entry Criteria
Type of Event: Workshop                                                There are no entry criteria for this workshop. If you have any
                                                                       questions on your suitability for this course, do not hesitate to
Length of Event: 1 day
                                                                       call the ARCS Business Office on (02) 8905 0829.
Dates                                                                  Type of Event: Workshop
Sydney: 26-Nov-08, 01-Apr-09                                           Length of Event: 2 days
Melbourne: 06-May-09
                                                                       Dates
                                                                       Sydney: 06-Nov-08
                                                                       Melbourne: 24-Feb-09



                                                        2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                        27
 BUSINESS WRITING SKILLS                                               ADVANCED BUSINESS
                                                                       WRITING SKILLS

 Who Should Attend                                                     Who Should Attend
 This course is suitable for people who want to develop or refresh     This course is suitable for people who are confident in their basic
 their basic writing skills, and for anyone who feels that their       writing skills and would like to further extend their capabilities,
 written work does not reflect their overall level of professionalism   and for anyone who wants to upgrade their skills and knowledge
 and is keen to improve their ability in this area.                    in preparation for career advancement.
 Course Overview                                                       Course Overview
 This introductory one day course is designed to help you acquire      This advanced one day course focuses on more complex
 the fundamental skills and knowledge needed to produce                writing tasks and techniques, such as using connectives to
 effective business documents and present a professional image         link sentences, paragraphs and ideas to help your writing flow
 as a writer. An extensive range of topics will be covered including   smoothly. Additional competencies covered include report-
 essential aspects of grammar and style, writing in Plain English,     writing, writing policies, procedures and work instructions, and
 writing letters and emails, document layout and proofreading.         persuasive writing - the art of convincing a reader to adopt your
 You’ll consolidate your learning through individual and group         point of view and carry out any actions you request. There will be
 exercises, and will finish the day with a renewed interested in        opportunities throughout the day for discussion and practice.
 the English language and its power as a communications and
                                                                       Course Highlights
 customer service tool.
                                                                       • Connectives: using connectives (linking words) to link
 Course Highlights                                                       sentences and paragraphs, construct arguments, help writing
 Effective Business Writing: key features of written English,            to flow smoothly and add variety and interest to writing
 informal-formal writing styles, benefits of writing effectively and    • Constructing paragraphs: organising blocks of text into
 business writing as a customer service tool                             paragraphs and sections in a structured and logical manner
 Tools and Planning: surveys online and other tools available to       • Report-writing: types of reports, report structure, online tools,
 the business writer and explains how to plan writing tasks              writing objectively, writing conclusions and recommendations,
                                                                         and writing Executive Summaries
 Writing Style: covers the “building blocks” of writing including
                                                                       • Persuasive Writing (persuading readers to adopt a particular
 basic grammar, use of Active and Passive voices, spelling,
                                                                         point of view and/or take requested actions): writing
 punctuation, business vocabulary, writing in Plain English and
                                                                         proposals, constructing a persuasive argument, language
 form of address
                                                                         structures
 Letters and Emails: business correspondence and email                 • Policies & Procedures (Work Instructions): policy
 guidelines, standard professional layouts for 1- and 2-page             guidelines and structure, procedure-writing guidelines
 letters, setting out information and use of tables, charts              and language structures
 and graphics                                                          • Course participants will also receive information on writing
 Proofreading: the importance of proofreading as well                    Performance Reviews and Setting & Measuring Objectives
 as spell checking, common errors and areas where errors
                                                                       Entry Criteria
 are often overlooked.
                                                                       To get the most out of this workshop you should have completed
 Entry Criteria                                                        the “Business Writing Skills” course or have more than two
 There are no entry criteria for this workshop. If you have any        years’ experience in a role requiring written communication
 questions on your suitability for this course, do not hesitate to     skills for business purposes. If you have any questions on your
 call the ARCS Business Office on (02) 8905 0829.                       suitability for this course, do not hesitate to call the ARCS
 Type of Event: Workshop                                               Business Office on (02) 8905 0829.

 Length of Event: 1 day                                                Type of Event: Workshop
                                                                       Length of Event: 1 day
 Dates
 Sydney: 15-Aug-08, 27-Feb-09                                          Dates
 Melbourne: 23-Jul-08, 22-Jul-09                                       Sydney: 22-Aug-08, 10-Mar-09
                                                                       Melbourne: 25-Jul-08, 24-Jul-09




28    ARCS AUSTRALIA
                                                    CONFERENCES AND OTHER EDUCATIONAL OFFERING – DATES FOR THE DIARY




CONFERENCES AND OTHER EDUCATIONAL OFFERING
– DATES FOR THE DIARY

 2008 ANNUAL                                         ANNUAL SCIENTIFIC                                    2008 MELBOURNE
 GENERAL EDUCATION                                   CONGRESS 2009                                        ANNUAL DINNER
 MEETING (AGEM)
 ARCS Annual General Education                       Annual Scientific Congress 2009 will                  The Melbourne ESC Annual Dinner will
 Meeting or AGEM this year will be                   be held at Sydney Convention and                     be held on 13 November 2008. It is
 held in Sydney on 20 November 2008.                 Exhibition Centre, Darling Harbour on                fast becoming the must attend event for
 The ARCS Board and the Business                     the 1 – 3 June 2009.                                 our Melbourne members. Based on the
 office intend to ensure the agenda will                                                                   last few years it promised to be just the
                                                     Who Should Attend:
 provide members with updates and                                                                         right mix of education and networking.
 discussions on local and global trends              • Those working in all the many                      Avoid disappointment and mark this
 and initiatives impacting our industry. An            disciplines associated with                        date in your diaries.
 important part of this meeting will be the            developing therapeutic products in
 Annual General Meeting (AGM) of the                   the Pharmaceutical, Biotech or
 Association. Come and have your say                   Device Industry
 and get involved.                                   • Associates, Team Managers,
                                                       Project Leaders, Directors – 40% of
                                                       attendees in past years described
                                                       themselves as Team Leaders,
                                                       Directors or Senior Management
                                                     • Research staff in hospitals or
                                                       academic institutions




         Osmond-Russell Scholarship


         Do you want to undertake a research project, expand your own knowledge, raise your profile within ARCS and help to
         increase the knowledge of other ARCS members? If so, would $10,000 help? If the answer is yes, why now apply the
         Osmond-Russell Scholarship.


         What is the Osmond-Russell Scholarship?
         In memory of Andrea Osmond-Russell, an active member of ARCS, who’s life was tragically cut short after a car accident, the
         ARCS Board and members established a Scholarship in recognition of her very positive contribution to ARCS during the early
         years. The aim of the Osmond-Russell Scholarship is to encourage ARCS members to improve their skills by pursuing study or
         research in areas that may be of interest to the ARCS membership, or attending international conferences on topics relevant to
         the membership.

         Eligibility
         All ARCS full members are eligible to apply for the Scholarship. The challenge is to develop a proposal which will be of individual
         benefit to your knowledge and development through education and experience and will also contribute to other ARCS members
         in some way. For full details please review the “Awards/Scholarships” section of the ARCS website, www.arcs.com.au. Here you
         will find ideas that may help kick start your application, as well as the terms and conditions of the scholarship and details of how
         to apply.

         This is a fabulous opportunity to broaden your horizons, expand your knowledge or to develop new skills with the
         assistance of a well-established and prestigious scholarship - worth up to $10,000!




                                                         2008 – 2009 ARCS AUSTRALIA PROFESSIONAL DEVELOPMENT BROCHURE                                 29
        Become a Member of
        ARCS Australia
        The Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical
        Industry (ARCS Australia) is the professional Association that supports scientists involved
        in the development of products. ARCS is also a premium provider of education to
        members and the industry.
        ARCS’ Mission is to:
        1. Promote education in a broad range of disciplines including regulatory affairs,
           clinical research, health economics, medical devices, diagnostics and medical
           information in order to enhance the professional competency of its members
        2. Promote the exchange of information and experience between members
        3. Establish the professional identity of personnel involved with regulatory
           affairs, clinical research, health economics, medical devices, diagnostics and
           medical information
        4. Establish effective communication with other organisations influencing the
           Pharmaceutical Industry.
        ARCS Membership entitles you to a number of benefits and services including:
        •    25 - 50% discount on all ARCS educational events
        •    A complimentary seminar voucher upon joining
        •    Subscription to the bimonthly ARCS Newsletter
        •    Subscription to the ARCS News Bulletin and ARCS Events Bulletin providing you with
             valuable industry news, industry events, employment and information on upcoming
             ARCS training courses and events
        •    Eligiblity for annual scholarships and awards
        •    The opportunity to network with your peers, exchange ideas, problems, solutions
             and contacts
        •    The opportunity to take a lead in developing much needed seminars and education
             program for industry with like-minded, enthusiastic colleagues by joining our
             Education Subcommittees (ESCs)
        •    Access to a library of links to organizations, journals and regulatory information in
             the members’ only section of the ARCS website
        •    Access to a library of presentations and articles from seminars, conferences
             and Newsletters
        •    15 - 20% discount on ARCS Training Room hire
        •    45 lecture theatre style and 20 classroom style




            Additional Member Benefits
                                    DIA eMembership - 50% discount off Standard Membership
                                    Drug Information Association (DIA) is the premier, member-driven, not-for-profit association
                                    in the pharmaceutical and related healthcare industries. DIA is proud to offer ARCS members
                                    50% discount off Standard Membership by offering eMembership at a cost of US$65.00.
                                    Members with an eMembership receive DIA publications electronically, rather than in hard
                                    copy. eMembership gives you access to a wide variety of activities and resources, including
                                    full access to members-only areas of the DIA website.


                                    NSW Enterprise Workshop – 10% discount for ARCS Members
                                    For 25 years the NSW Enterprise Workshop entrepreneurial business and management
                                    development program has provided a structured analytical process for identifying and
                                    evaluating commercial opportunities. The program is aimed at developing entrepreneurship,
                                    innovation and management skills. ARCS Members are now entitled to a 10% discount to
                                    participate in the NSW Enterprise Workshop. The Workshop runs two programs each year
                                    that start at the end of March and mid July. Further information is available
                                    atwww.enterpriseworkshop.com.au.



        To take advantage of these benefits and more, join today at www.arcs.com.au
        Professional Development for the Therapeutics Industry™
1
30   ARCS AUSTRALIA
CALENDAR DATES
Sydney                                                                     Melbourne
Overview of Drug Development                                   17-Jun-08   Business Writing Skills                                          23-Jul-08
Managing Common GCP Issues Effectively                         18-Jun-08   Advanced Business Writing Skills                                 25-Jul-08
in Your Clinical Project
                                                                           Understanding the GCP Audit Process                            26-Aug-08
CRA1 - Essential GCP Training for New CRAs                     19-Jun-08
                                                                           Requirements for Quality – Module 3 and Module 2.3             02-Sep-08
Introduction to Australian Regulatory Affairs                  23-Jun-08   (Day 1) - NEW COURSE
Bayesian Methods in Health Economics                           14-Jul-08
                                                                           Regulation of Pharmaceuticals in the USA - NEW COURSE           02-Oct-08
CRA1 - Essential GCP Training for New CRAs                    07-Aug-08
                                                                           Introduction to Australian Regulatory Affairs                   08-Oct-08
Fundamentals of Project Management                            14-Aug-08
                                                                           How to Effectively Select Investigational Sites (Workshop)      13-Oct-08
Business Writing Skills                                       15-Aug-08
                                                                           CRA1 - Essential GCP Training for New CRAs                      14-Oct-08
How to Effectively Select Investigational Sites (Workshop)    19-Aug-08
Advanced Business Writing Skills                              22-Aug-08    CRA2 - Managing Your Trial Sites More Effectively               16-Oct-08
Conducting Clinical Research - Essential GCP Training         28-Aug-08    Overview of Drug Development                                    01-Nov-08
for study Coordinators                                                     Melbourne Annual Dinner                                        13-Nov-08
Requirements for Quality – Module 3 and Module 2.3            04-Sep-08    Applying Bioavailability and Bioequivalence (BABE)              27-Nov-08
(Day 1) - NEW COURSE                                                       Guidelines - NEW COURSE
Overview of Drug Development                                  09-Sep-08    Fundamentals of Project Management                             03-Dec-08
Project Management                                            10-Sep-08    Project Management                                             03-Dec-08
CRA1 - Essential GCP Training for New CRAs                    15-Sep-08
                                                                           Managing Common GCP Issues Effectively                         04-Dec-08
CRA2 - Managing Your Trial Sites More Effectively             17-Sep-08    in Your Clinical Project
Regulation of Pharmaceuticals in the USA - NEW COURSE         30-Sep-08    Industry Associations Annual Update                                Feb-09
Managing and Resolving Conflict in Teams                       23-Oct-08    The New Manager Training Program - NEW COURSE                   24-Feb-09
Assertiveness techniques for the Workplace                    24-Oct-08
                                                                           Introduction to Australian Regulatory Affairs                   24-Mar-09
Clinical Statistics for Nonstatisticans                       27-Oct-08
                                                                           How to Effectively Select Investigational Sites (Workshop)      20-Apr-09
Introduction to Australian Regulatory Affairs                 29-Oct-08
                                                                           CRA1 - Essential GCP Training for New CRAs                      21-Apr-09
Applying Bioavailability and Bioequivalence (BABE)            06-Nov-08
Guidelines - NEW COURSE                                                    CRA2 - Managing Your Trial Sites More Effectively               23-Apr-09
The New Manager Training Program - NEW COURSE                 06-Nov-08    Managing and Resolving Conflict in Teams                         29-Apr-09
CRA1 - Essential GCP Training for New CRAs                    13-Nov-08    Assertiveness techniques for the Workplace                      30-Apr-09
Annual General Education Meeting (AGEM)                       20-Nov-08    Conducting Clinical Research - Essential GCP Training           30-Apr-09
Dealing with Difficult people                                  24-Nov-08    for study Coordinators
The Art of Negotiation                                        25-Nov-08    Dealing with Difficult People                                   01-May-09
Increasing Your Effectiveness at Work                         26-Nov-08    The Art of Negotiation                                         05-May-09
Managing Common GCP Issues Effectively                        11-Dec-08    Increasing Your Effectiveness at Work                          06-May-09
in Your Clinical Project
                                                                           Clinical Statistics for Nonstatisticans                         07-May-09
Fundamentals of Project Management                            12-Dec-08
                                                                           Overview of Drug Development                                    15-Jun-09
Industry Associations Annual Update                              Feb-09
                                                                           Fundamentals of Project Management                              16-Jun-09
Advanced Clinical Statistics for Nonstatisticians             16-Feb-09
                                                                           Managing Common GCP Issues Effectively                           21-Jul-09
CRA1 - Essential GCP Training for New CRAs                    19-Feb-09
                                                                           in Your Clinical Project
Overview of Drug Development                                  25-Feb-09
                                                                           Business Writing Skills                                          22-Jul-09
Business Writing Skills                                        27-Feb-09
                                                                           Advanced Business Writing Skills                                 24-Jul-09
Advanced Business Writing Skills                              10-Mar-09
Introduction to Australian Regulatory Affairs                 11-Mar-09    Brisbane
Understanding the GCP Audit Process                            17-Mar-09   Project Management                                              24-Jun-08
CRA2 - Managing Your Trial Sites More Effectively             19-Mar-09    Overview of Drug Development                                    27-Jun-08
Managing and Resolving Conflict in Teams                       23-Mar-09    CRA2 - Managing Your Trial Sites More Effectively                17-Jul-08
Assertiveness Techniques for the Workplace                    24-Mar-09
                                                                           CRA1 - Essential GCP Training for New CRAs                       29-Jul-08
Dealing with Difficult People                                  25-Mar-09
                                                                           Conducting Clinical Research - Essential GCP Training            31-Jul-08
Conducting Clinical Research - Essential GCP Training         26-Mar-09    for Study Coordinators
for Study Coordinators
                                                                           CRA1 - Essential GCP Training for New CRAs                       14-Jul-09
How to Effectively Select Investigational Sites (Workshop)    30-Mar-09
                                                                           CRA2 - Managing Your Trial Sites More Effectively                16-Jul-09
The Art of Negotiation                                        31-Mar-09
                                                                           Managing Common GCP Issues Effectively                           29-Jul-09
Increasing Your Effectiveness at Work                          01-Apr-09
                                                                           in Your Clinical Project
CRA1 - Essential GCP Training for New CRAs                     02-Apr-09
                                                                           Conducting Clinical Research - Essential GCP Training            30-Jul-09
Clinical Statistics for Nonstatisticans                        06-Apr-09   for study Coordinators
Fundamentals of Project Management                             08-Apr-09
                                                                           Canberra
Project Management                                            06-May-09
18th ARCS Annual Scientific Congress                           01-Jun-09    Requirements for Quality – Module 3 and Module 2.3             11-Sep-08
                                                                           (Day 2) - NEW COURSE
CRA1 - Essential GCP Training for New CRAs                     18-Jun-09
Overview of Drug Development                                   22-Jun-09   TGA Overview Day                                               Oct/Nov-08
Managing Common GCP Issues Effectively                         23-Jun-09   TGA/Industry Update Day                                        Oct/Nov-08
in Your Clinical Project                                                   An Introduction for the Process of Listing a Medicine on the      Dec-08
Introduction to Australian Regulatory Affairs                  24-Jun-09   Australian Pharmaceutical Benefits Scheme (PBS)

                                                     To register, please visit www.arcs.com.au
                                  ™

Professional Development for the Therapeutics Industry™


ARCS Australia Ltd | ABN 25 050 334 444
Suite 904, 28 Clarke Street, Crows Nest NSW 2065 Australia
T 02 8905 0829 F 02 8905 0830 E arcs@arcs.com.au W www.arcs.com.au

								
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