GMP and Regulatory Expectations US seminar

							                                                                                                                    Net Zealous




    USA Seminar 2012 at San Diego

    GMP and Regulatory Expectations
    for Early IND Products
    by   Dr Steven S. Kuwahara
    On 5th and 6th April, 2012 at San Diego




About GlobalCompliancePanel:

GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high
quality regulatory and compliance-related services.

At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,
Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we
have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these
sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective
experience are associated with us.

Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT
Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group
viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as
J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.


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            USA Seminar 2012 at San Diego

               Dr Steven S. Kuwahara
               Founder & Principal, GXP Biotechnology, LLC

About Speaker:
Dr. Kuwahara currently heads GXP BioTechnology . He is an experienced analytical biochemist who has applied his
knowledge to the quality control area of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in
relation
to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and
nutritional supplements.

Dr. Kuwahara has written many papers and book chapters, and serves on the editorial advisory boards of BioPharm,
BioQuality, Journal of Validation Technology, and Journal of GXP Compliance. For the last of these, he also writes a
column called “The GLP Forum.”

He has held certifications such as CQA, CQT, and CQE from the American Society of Quality, and was certified RAC
by the Regulatory Affairs Professionals Society.



Past Seminars




                                                             Date and Venue:
                                                             April 5th and 6th, 2012 at San Diego

                                                             Will be announced soon
                                                                         USA Seminar 2012 at San Diego
Seminar Content:                                                                            Conference timings: 9 AM PDT to 5 PM PDT

Why should you attend:
This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will
not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development
process. The course will present these items in the order of product development from the point of R & D activities to the
completion of Phase 2 clinical trials.
Day 1 - 5th April 2012                                                Day 2 - 6th April 2012


  Lecture 1: Very Early Stages                                           Lecture 5: GMPs for Phase 1 IND
  „ The need for documentation of matters that will                      products
      affect downstream work.
                                                                         „ The scope of the guidance document
  „ The effects of ICH Q8
      – Impact on R & D activities                                       „ The second guidance document covering the
                                                                            GMPs
      – Risk analysis and design control at this stage
                                                                         Lecture 6: GMPs for Phase 1 continued
  Lecture 2: GLP requirements
                                                                         „ A presentation covering what GMPs are
  „ Animal studies                                                          required at this stage.
      – Toxicology and pharmacokinetics
                                                                         „ What has been omitted from the GMPs for
  „ Estimating the Maximum Safe Starting Dose                               Phase 1
      – A review of the guidance document

                                                                         Lecture 7: Requirements for Phase 2
  Lecture 3: Early Pre-IND Studies
                                                                                    INDs
  „ Understanding exploratory Studies
                                                                         „ The full GMPs resume, but do they?
      – Definitions and the IND that will be
         withdrawn                                                       „ Phase 2 studies and the transition to full GMPs.
  „ Orphan Drugs
                                                                         „ CMC requirements
  „ Drugs studied under the Animal Rule
      – What they are and how to conduct the
         studies                                                         Lecture 8: Preparing for IND Meetings

  Lecture 4: Meetings and Preparing for                                  „ Phase 1 meetings

             the IND                                                     „ Pre-phase 2 meetings
  „ Information required for the Phase 1 IND
                                                                         „ Phase 2 meetings
      – The CMC requirements that will be needed.
  „ Pre-IND Meetings with FDA


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                                                                          USA Seminar 2012 at San Diego

What you get:
1. Learning Objectives
                                                                                          Pricing List:
2. Participation certificates                                                             1. Price for One Delegate pass
3. Interactive sessions with the US expert                                                   $1895
4. Post event email assistance to your queries.                                              (Between March 23th to April 25th)
5. Special price on future purchase of web based trainings.                               -----------------------------------------
6. Special price on future consulting or expertise services.                              2. Early bird price for one Delegate
7. Special price on future seminars by GlobalCompliancePanel.                                pass $1695
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,        (Between February 16th to March 22th)
    notepad and pen.                                                                      -----------------------------------------
9. Networking with industry's top notch professionals                                     3. For discounts on multiple
                                                                                             registrations, contact customer
                                                                                             care at 1800 447 9407
                                                  Companies that will benefit:
                                                  † Small Molecule Drug Companies
                                                                                          Professionals who will benefit:
                                                  † Biologic Companies                    £ Directors
                                                  † API and Generics Manufacturers        £ Managers
                                                                                          £ Supervisors, and lead workers in
                                                                                            Regulatory Affairs
How to Register:                                                                          £ Quality Assurance and Quality Control
                                                                                          £ Workers who will prepare GMP
v   Register online. Use your American Express, Visa or MasterCard
                                                                                            documents for early phase products as
v   For group discount of more than 5 attendees call 800-447-9407                           well as those who will review these
v   Call +1 - 800-447-9407 or Fax your PO: 302-288-6884                                     documents
                                                                                          £ Regulatory affairs workers who will need
v   Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,
                                                                                            to deal with submissions covering early
     6552 Palisades Dr. Centreville, VA 20121
                                                                                            phase products.




    Contact Information:
    Event Coordinator
    Toll free: 1800 447 9407
                                                                                        Kindly get in touch with us for
    Fax: 302 288 6884
    Email: support@globalcompliancepanel.com
                                                                                           any help or information.
    GlobalCompliancePanel                                                               Look forward to meeting you
    NetZealous                                                                                  at the seminar
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    Suite 1200, Wilmington,
    DE 19801..




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