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					       Education Programme for Post-graduate Students of the Graduate School GUIDE


Welcome to Gui de

Dear PhD student,

Your research as a PhD student is part of the research programme of the graduate school GUIDE
(Groningen University Institute for Drug Explorat ion).

GUIDE is a graduate school with bio med ical and pharmaceutical research as its main theme. In the
framework of GUIDE, interaction is fostered between clinical, preclin ical and pharmaceutical research
groups. The interaction takes place between groups studying the pathophysiology of disease, groups
developing new drugs and optimising drug delivery techniques, and groups evaluating the use of drugs
for these diseases.

GUIDE offers a wide spectrum of courses for additional t rain ing of PhD -students, including courses
preparing the PhD-students for their research tasks, and in-depth courses specifically relating to their
own research project. The remainder of the programme has been divided into courses on methodology,
courses on pathophysiological concepts and courses on pharmaceutical research.

The training programme contains a detailed overview of all GUIDE courses, with appro ximate periods
in wh ich courses are given. Further information can be obtained at ms. Maaike Bansema‘s, GUIDE‘s
registration officer.
Phone: 050-363 8409 or -3163.
E-mail: m.h.bansema@med.u mcg.n l
Web-site: www.rug.nl/ GUIDE/

In the Introduction section of this programme you can read all about credit points, procedures and
financing.

At the start of your appointment as a PhD-student, you will receive both the Training & Supervision
Plan and the GUIDE Log (journal). We would like you to fill out the TSP and send it to GUIDE office.
The log is for your own yse, to monitor your study and research progress. We will ask you to send us a
copy of this log at the end of each calendar year.

You will regularly be informed about GUIDE courses, seminars, and other activities. If you have any
queries or need more information, do not hesitate to contact the undersigned.

On behalf of the board and management of GUIDE,



Ms Riekje Banus,                                                                 Prof Han Moshage,
Education coordinator.                                                           Scientific d irector.


GUIDE office, Ant. Deusinglaan 1. bldng 3217, 9713 A V Groningen. Telephone no. (050) 363 3163.
Fax no.: (050) 363 2612.

GUIDE web site: www.rug.nl/ GUIDE




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


                                                        GUIDE Graduate School - 2006 -

TABLE OF C ONTENT                                                                page


Advanced Drug Delivery and Drug Targeting                                        29
Advanced Immunology                                                              27
Application of Modern Techniques in Life Sciences                                20
Apply for courses                                                                 9
Bio-in formatics                                                                 25
Co mpulsory activities                                                            5
Conferences & Lectures                                                            5
Contacts GUIDE office                                                             7
Courses and other research activities - overview                                 10
Curriculu m                                                                       3
Design, Conduction and Evaluation of a Clinical Trial                            31
Early Su mmer Meeting (ESM)                                                       5
EC                                                                               10
EC extra                                                                          6
Ep idemio logy and Applied Statistics                                            26
Funds and Financing                                                               6
Good Manufacturing Pract ice: GMP                                                19
Good Research Practice: GLP/ GCP                                                 18
Intermediary/confident                                                            9
International Seminar Programme (ISP)                                             5
Introduction Course                                                              11
Laboratory Animal Science                                                        16
Lectures by other Schools or Institutes                                           5
Log/Journal                                                                       5
Medical Statistics                                                               15
Membranes, Signaling and Transport                                               30
Microbiology / Infect ious Diseases                                              28
Microbiology Safety                                                              23
Pharmacoepidemio logy and Drug Policy                                            32
PhD Categories                                                                    4
Presentation Skills                                                              14
Project Management for Scientific Research                                       12
Publishing in English                                                            13
Registration                                                                      5
Research focus                                                                    3
Research Institutes GUIDE                                                         8
Science to the Market                                                            17
Study Requirements                                                                4
Techniques of Molecular Biology                                                  24
Train ing & Supervision Plan (TSP)                                                5
Working with Radioactive Substances                                              21
Working with Isotopes                                                            22




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         Education Programme for Post-graduate Students of the Graduate School GUIDE


INTRODUCTION

Research focus
Research groups of both the Faculty of Mathematics & Natural Sciences (Pharmacy) and the Faculty
of Medical Sciences (UMCG) are situated in Graduate School GUIDE.

The GUIDE research programma is based on the concept that the process of drug discovery is driven
by the interaction between knowledge concerning disease and the knowledge concerning drugs. Three
major research themes are defined on the basis of this concept.

The first theme starts from the idea that new therapeutic modalit ies will be d iscovered through an
improved understanding of the underlying pathophysiology of disease. The main focus is organ failure
(with emphasis on lung heart, liver and kidney), as a result of chron ic disease (including cancer) or
following organ transplantation. The participation of strong clin ical g roups warrants successful
implementation of the research efforts in this theme. This research is co mplementary to key areas of
patient care of the University Medical Center Groningen, e.g. co mprehensive clinical transplantation
(lung, heart, liver, and kidney transplantation) and the chronic disease programme.

The second theme concerns the development of novel medicines by means of advanced drug delivery
and ―molecular-b iological interventions‖, with a special focus on controlled and site specific d rug
delivery and targeting. The latter is based on unique expert ise in carrier systems such as monoclonal
antibodies, synthetic polymers, amph iphiles, liposomes, neoglycoproteins and virosomes. The
deliveries of therapeutic peptides, genes or anti-sense oligonucleotides are a few examp les of the
available modalities.

The third theme comp rises post-marketing studies carried out on new medicines and medication
through epidemiological evaluation, using patient controlled methodology.

GUID E Research Institutes
The above-mentioned themes have been divided into research institutes. GUIDE covers nine
institutes1 :
GIKD Groningen Research Institute for Kidney Diseases.
CVC       Card iovascular Centre.
GRIA C Groningen Research Institute for Asthma and COPD.
CLDS Centre for Liver, Digestive and Metabolic Diseases.
TRIO Transplantation, Immunology and Inflammat ion.
NNOC Northern Netherlands Oncology Centre.
BDDD Biopharmaceuticals: Discovery, Design and Delivery.
S&A       Synthesis and Analysis.
PEDP Pharmacoepidemio logy and Drug Policy.


GUID E Curriculum
GUIDE offers a wide spectrum of courses for additional t rain ing of PhD students 2 . These courses are
on the one hand intended to prepare PhD students for their research tasks. On the other hand, some
courses that are on offer have been desgined in order to improve the students‘ future position on the
labour market.

The most important aspect of training PhD students is to see that fruitful master-apprentice relat ions
can develop. GUIDE matches PhD students with expert researchers working in act ive research groups.
The expert researchers coach the PhD students through to defence of the dissertation. Journal club

1
    See overview on page 8.
2
    List of GUIDE courses on page 10.




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         Education Programme for Post-graduate Students of the Graduate School GUIDE


meet ings and regular research group meetings help to create an environment in wh ich the individual‘s
progress is measured and advanced. Participation in ―master classes‖, the GUIDE international seminar
programme, attendance of symposia and international congresses will further enrich the students‘
experience. Options to spend a brief period in a foreign institution for acquiring new skills are available
and encouraged by GUIDE staff.


STUDY REQUIR EMENTS

Every PhD student must be registered at a Graduate School. This applies to everyone preparing a PhD-
thesis. The curriculu m has a varied programme, wh ich gives all researchers working on a thesis the
opportunity to join in courses related to their research and circu mstances.

Apart fro m taking courses, it is important that the PhD students become familiar with activ ities related
to the transfer of knowledge, such as keeping up with professional literature, participation in work
discussion meetings and reference meet ings of the student's own working group and - in consultation
with the supervisor or promotor - of other working groups, active participation in local and national
scientific meetings and, as often as possible, international meetings.

The GUIDE postgraduate curriculu m is based on the European Cred it system. During the ‗standard‘
four years research project a number of 18 EC must be obtained. As there are several categories of
PhD students the required number of EC varies.

The GUIDE cert ificate is awarded upon obtaining the required number of EC, and will be presented at
the concluding Defence Ceremony.


PhD Categ ories                        Period of Research                          Required EC 3
PhD student                                    4                                          28
AIO                                            4                                          28
Bursaries                                      4                                          28
Bursaries                                     2-3                                         12
AGIKO/AIO                                      3                                          12
Pharmacists-in-training                        3                                          12
MD/PhD                                         2                                          11
Others (med spec., externals)               variable                                      t.b.d.


EC can be obtained by participating in the following activit ies 3 :
GUIDE courses,
Courses organised by other institutes (regional, national, international),
Research meetings, seminars, a.o.
Lectures in the International Seminar Programme,
Manuscript reviewing,
SMBWO programma (Foundation for Medical Biological Scientific Research).




3
    An overview of all act ivities and EC is on page 10.




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


REGISTRATION

Trai ning & Supervision Pl an (TSP)
Upon starting the research period, the PhD-student must contact GUIDE Graduate School to register by
means of the Training and Supervision Plan. The TSP must be signed by the PhD-student and his
promotor or supervisor. The TSP will be signed by the scientific director and the representative of
GUIDE‘s Educational Co mmittee on approval.

Log/Journal
After registration, the PhD-student will receive a (d igital) log to keep track of the research and
educational activities during his/her research period. The Ph D student is expected to send an
annual version to GUIDE office each year. After termination of the research period and before the
Defence Ceremony, the co mpleted log must be delivered at GUIDE office. The log, undersigned
by the doctoral candidate, the promotor, the scientifc d irector and the education coordinator, will
be enclosed with the GUIDE-certificate.

Compulsory acti vities
1. GUIDE Introduction Days.
2. Pro ject Management for Scientific Research.
3. GUIDE Annual Meeting for PhD-students and staff.
All PhD-students are obliged to join the GUIDE Introduction Days, the Course on Project
Management for Scientific Research as well as participate in GUIDE‘s Annual Meeting. External
doctoral candidates may be exempted fro m join ing the two courses, alt hough they are obliged to
join one or mo re general courses and one or more ‗in-depth‘ courses. Besides, they are expected
to present a poster at the annual meeting.

Ad 1. The introduction days are the best way to gain insight into the various aspects of the research
school, the organisational structures of university and hospital, depart ments, research and researchers.
Ad 2. The course on Project Management has been developed into an important tool for progress
monitoring. Its main aim is to prepare the PhD students for complet ing their thesis within the limited
time span of their research period. With this course, PhD-students learn to work within a pro ject
structure, having 2-3 annual fo llow up sessions.
Ad 3. Main aim of the GUIDE Early Su mmer meet ing is to encourage the research school‘s PhD
students to present their research and get acquainted with colleague researchers and research. All PhD
students get the opportunity to submit an abstact for the poster sessions. .


CONFERENCES & LECT URES

GUID E Early Summer Meeti ng (ES M)
The annual GUIDE symposium takes place in June. Its main aim is to encourage the graduate school‘s
doctoral candidates to present their research and find out a bit more about GUIDE‘s research and
researchers. All researchers – both staff and PhD students – attend this meeting. Besides, all PhD
students and postdocs are invited to submit an abstract for poster sessions and/or oral presentations.

GUID E Internati onal Semi nar Programme (ISP)
GUIDE supports research groups inviting (a) foreign speaker(s) by means of the International Seminar
Programme. GUIDE offers the opportunity to have the lecture announced on posters and mailing lists
to PhD students, and will to a certain extent cover the costs.

Lectures organised by other Schools or Institutes
GUIDE Ph D students may attend lectures by international lecturers in the field of one of GUIDE‘s
research subjects, organised by other graduate schools and institutes.




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


Extra EC can be obtained by joini ng lectures, workshops, master classes and seminars.

Action                                                                               EC
* Attending at least 6 guest lectures in the
International Seminar Programme                                                      1
* Active participation in at least 3 workshops
or master classes with an external guest speaker
in one of GUIDE research groups                                                      1
* Active participation in at least 20 seminars
within one of GUIDE research institutes                                              1
* Presentation (oral/poster) at (inter)national meet ings                            1
* Manuscript review – at least 2 manuscripts per research period                     1




FUNDS AND FINANCING

The financing of the training programme
Graduate School GUIDE receives an annual budget from the Faculty of Medical Sciences/University
Medical Center Groningen (UM CG) and the Faculty of Mathematics & Natural Sciences. This budget
is intended for the training of PhD-students. The budget is divided into (the organisation of) courses
and conferences, travel grants, and other financial support.

Partici pation in GUIDE courses
All GUIDE PhD students attend the GUIDE courses for free.

Attending conferences and other c ourses
The tuition fees are also used to enable PhD students to participate in other training activ ities. These
activities include national and international conferences as well as courses which are not offered by
GUIDE.

Financial support for these activities can be applied for by means of a GUIDE application form, wh ich
must be supported by a written reco mmendation fro m the supervisor. Be sure to send the application
form beforehand. Expenses relating to these activities will only be reimbursed if the Ph D student
participates in GUIDE courses. Reimbursement takes place afterwards.

Financial support for attending (inter)national conferences:      annual € 600,- max.
Financial support for attending external courses                  annual € 600,- max.

Printing costs PhD thesis
A contribution towards printing costs of the dissertation is available to an amount of         € 227,- .
When acquiring the required nu mber o f EC, and thus the GUIDE cert ificate the
financial support will mount up to                                                            € 454,-

Application forms are availab le at GUIDE office: m.h.bansema@med.u mcg.nl and should be submitted
in advance, signed by both PhD student and supervisor.




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


CONTACTS

GUIDEo ffice@med.u mcg.n l . Telephone number: (050) 363 3163.
Web site: www.rug.nl/ GUIDE/

Management:
Prof.dr Han Moshage, scientific director.
prof.dr Ben Westerink, deputy scientific d irector, representative of the Groningen Institute for
Pharmacy (GRIP).

Support staff:
Astrid Bakker, management assistant.
Dr. Peter Braun, research coordinator.
Dr. Herman Woerdenbag, research coordinator, represenative of the Groningen Institute for Pharmacy
(GRIP).

Course enrolment : Maaike Bansema, tel.nr. (050) 363 8409.
Education coordinator: Riekje Banus.




                                                   ***




                                                                                                    7
       Education Programme for Post-graduate Students of the Graduate School GUIDE


GUID E RES EARCH INS TITUTES




                  Institute/Programme             Research lines
Disease related   Groningen Research              Mechanisms underlying progressive renal function
programmes        Institute for Kidney Diseases   loss
                  - GIKD                          Antiproteinuric treat ment regimens
                                                  Microalbu minuria and renal function loss
                  Card iovascular Centre          Experimental yeart failure
                  - CVC                           Clin ical heart failure
                                                  Atrial fibrillation
                  Groningen Research              Ep idemio logical risk factors
                  Institute for Asthma and        Genetic background
                  COPD - GRIAC                    Pathophysiology of allergen-, environ ment- and
                                                  smoke-induced diseases
                                                  Assessment, modulation and intervention in diseases
                                                  severity and progression
                  Centre for Liver, Digestive     Transport and metabolis m
                  and Metabolic Diseases          Target identification
                  - CLDS
                  Transplantation,                Autoimmune diseases
                  Immunology and                  Transplantation
                  Inflammation - TRIO             Infections
                                                  Tumor immunology
                  Northern Netherlands            Cancer: genes, mutations and their consequences
                  Oncology Centre - NNOC          Hematopoetic development and hemato-oncology
                                                  Translational Oncology
                                                  Clin ical studies
Expertise         Biopharmaceuticals:             Pharmaceutical biology and biotechnology
related           Discovery, Design and           Pharmacokinetics and drug delivery
programmes        Delivery - BDDD                 Pharmaceutical technology, biopharmacy and
                                                  industrial pharmacy
                                                  Therapeutic gene modulation
                  Synthesis and Analysis          Analytical biochemistry
                  – S&A                           Pharmaceutical analysis
                                                  Bio monitoring and sensoring
                                                  Medicinal chemistry
Ep idemio logic   Pharmacoepidemio logy and       Pharmacoepidemio logy and drug policy
programmes        Drug Po licy - PEDP             Rational drug use




                                                                                                    8
       Education Programme for Post-graduate Students of the Graduate School GUIDE


GEN ERAL INFORMATION AND HOW TO APPLY



You may apply at any time for one or mo re courses by mailing to m.h.bansema@med.u mcg.nl
Maaike Bansema takes care of registration and can give you information about the courses concerning
dates, locations, times and teachers of all courses. You should register for each course separately.

 When you have registered, your attendance is considered to be compulsory.
Canceling participation after the last reminder, imp lies a lowering of GUID E financial support for
your congresses and courses.

An update overview can be found at the GUIDE web-site and in every ‗GUIDElines‘, the newsletter of
Graduate School GUIDE. ‗GUIDElines‘ appears 4-5 times a year.


Intermedi ary
If you experience work related problems, you can contact the education coordinator: Riekje Banus.
Your problems will be discussed in a strictly confidential way. So metimes it just helps if you can talk
to someone outside your own environ ment. But if necessary -and only on your own request - she can
med iate and may help solve your problem.

E-mail: h.m.m.banus@med.u mcg.nl
Telephone: 050-363 2853.




GUIDE office
Ant. Deusinglaan 1 Bldng 3217, 7th floor
9713 A V Groningen
P.O.Bo x 196
9700 AD Groningen
GUIDEo ffice@med.u mcg.n l
Telephone number: 050-363 3163




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          Education Programme for Post-graduate Students of the Graduate School GUIDE


COURS ES AND OTHER RES EARCH ACTIVITIES                                          EC 4



General courses
Introduction to GUIDE                 - compulsory -                             1
Project Management for
         Scientific Research          - compulory -                              2
Publishing in English                                                            2
Presentation Skills                                                              2
Medical Statistics                                                               2
Laboratory Animal Science                                                        3
Science to the market                                                            6

Methodol ogical & practical courses
GLP/ GCP Good Laboratory
         Practice/ Good Clinical Practice                                        3
Good Manufacturing Pract ice                                                     1
Application of Modern
Techniques in Life Sciences                                                      4
Working with Radioactive Substances                                              2
Working with Isotopes                                                            3
Microbiological Safety                                                           1
Techniques of Molecular Biology                                                  4
Bioinformatics                                                                   1
Ep idemio logy and Applied Statistics                                            3

Biomedical & Pharmaceutical research courses
Advanced Immunology                                                              4
Microbiology and Infectious Diseases                                             1
Advanced Drug Delivery and Drug Targeting                                        3
Membranes, Signal Transduction and Transport                                     3
Design, Conduction and Evaluation of a Clinical Trial                            3
Pharmacopeidemio logy and Drug Policy                                            3

Acti ve partici pation in research groups
* Attending at least 6 guest lectures in the
International Seminar Programme                                                  1
* Active participation in at least 3 workshops
or master classes with an external guest speaker
in one of GUIDE research groups                                                  1
* Active participation in at least 20 seminars a year
within one of GUIDE research institutes                                          1
* Manuscript review – reviewing at least
2 manuscripts per PhD student per research period                                1
* Presentation (oral/poster) at (inter)national meet ing                         1

GUID E Early Summer Meeti ng                   - compulsory -                    1
Submit an abstract. Present a poster.
Excellent abstracts will be selected for an oral presentation.



4
    EC: Eu ropean Cred it




                                                                                     10
       Education Programme for Post-graduate Students of the Graduate School GUIDE


INTR ODUCTION TO GUIDE                                                                     GUIDE

Compulsory course for first year Ph D students

Aim
Gain ing an insight into the various aspects of the GUIDE training programme and the organis ational
structure of the school, the University, and the University Medical Center Groningen.
•   Getting to know GUIDE staff members and fellow-graduate students from other research groups.
    These contacts may benefit you at a later stage, when you need specialist help or expertise to
    further your research.
•   Beco ming aware of the position of your field of research in society.

Organisation
The course covers 2 days, and is organized at a remote site in the country. Most of the time, you will be
among fello w post-graduate students.
Participants will get to know each other by presenting and discussing their research projects, carrying
out group assignments around the topics presented, group discussions, meetings with guest le cturers,
and social activ ities.

Study load: 1 EC.

Frequency: twice a year.




Information/ Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                       11
       Education Programme for Post-graduate Students of the Graduate School GUIDE


PROJECT MANA GEMENT F OR SC IENTIF IC RESEARCH                                              GUIDE

Compulsory course for PhD students


Aim
Learn ing to work within a project structure as an effective method of scientific research that should
result in a doctoral dissertation.

Intended for
PhD students in GUIDE and UM CG

Organisation
Two-day train ing course in the first year of the post-graduate training programme, with a follow-up
seminar within 3 months. The course will take place at an attractive setting in the country, wh ere you
will have ample opportunity to get to know your colleagues.

Follow-up seminars are organised during the 2nd and 3rd year of your PhD appointment. Main topic of
these follo w-up sessions is the progress of your research project. They take about 3 hours. Note that
the follow-ups are compulsory.

Content
The essential elements of working within a pro ject structure; the project assignment; the ‗interplay of
forces‘ surrounding a project; timetabling; decision-making; managing a project; writ ing a project
assignment; organisational cultures; project-friendly cu ltures; the consultation interview; the phase
model of research projects.
The participants will not only become familiar with the theory, but will also practice useful skills by
means of assignments and exercises. The follow ups are especially aimed at preparing the PhD students
for co mplet ing their thesis within the limited time span of their research period.

Study load: 2 EC.

Frequency: 2-3 times a year.




Information/ Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                          12
       Education Programme for Post-graduate Students of the Graduate School GUIDE


PUBLISHING IN ENGLISH                                                       LANGUAGE CENTER R UG


Aim
Learn ing to use scientific English in written presentations.

Intended for
University staff who (intend to) write art icles or a dissertation in English.

Organisation
Seminars: 12 x 2 hours in the morn ing (09.00-11.00) or afternoon (16.00-18.00).

Content
Although linguistic aspects such as, for example, spelling, conventions, structure, and style will have
their place in the course, the main emphasis will be on the grammar of scientific English in written
texts. Every two weeks, the participants are to hand in a text of around 1000 words written expres sly
for the course. Participants should therefore set aside at least 3 hours per week for ho mework. The
lecturer will use these texts to illustrate common mistakes. A reader with extensive background
material and exercises will also be used during the course.

Study load: 2 EC.

Frequency: several times per year.

Maxi mum number of partici pants: 12.




Information/ Enrol ment
Talencentrum RUG, Harmon iegebouw, Oude Kijk in ‗t Jatstraat 26. Telephone: 363.5802.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                          13
       Education Programme for Post-graduate Students of the Graduate School GUIDE


PRESENTATION SKILLS                                                                          GUIDE



Aim
Participants will be ab le to deliver an effective presentation in an English -speaking environment.

Intended for
GUIDE Ph D-students.

Course Organisati on
First afternoon:
4 hours of theory and preparation, including the following topics:


-   general presentation theory                                  - use of language
-   first impressions                                            - feedback rules
-   non-verbal commun ication                                    - interaction with audience
-   analysis of personal strenghts and weaknesses                - use of media
-   personal objectives                                          - lecturettes (2 minute presentations)
-   cultural differences in commun ication

Second day:
8 hours of presentations
The presentations will take p lace appro ximately one week after the theory session. Every participant
will deliver a 15 minute presentation in English. The presentations will be recorded on video.
Participants analyse their presentations and will receive feedback fro m g roup members and coach.

Work load
Self study (theory): 2 hours
Preparation of presentation: 6 hours

Study Load: 1 EC.

Language of i nstruction: English .

Frequency: Several t imes a year, depending on the number of applicants.

Maxi mum number of partici pants : 8.

Lecturer: ms Tanja Nobel.




Information/ Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                          14
       Education Programme for Post-graduate Students of the Graduate School GUIDE


MEDICAL STATISTIC S                                                                            NCG


Aim
Providing an introduction into statistical and methodological aspect s of the design, implementation,
and evaluation of scientific research. By using the SPSS package, the participants will learn to carry
out and interpret simple statistical analyses. The emphasis will be on the understanding of statistical
methods.

Intended for
Post-graduate students, university and hospital staff, others interested in this topic.

Organisation
The course consists of 10 morn ing sessions, which will be concentrated in 4 weeks (2-3 sessions per
week).

The course is part of the education programme of the Northern Centre for Healthcare Research (NCG)

Content
The textbook is Practical Statistics for Medical Research by D.G. Alt man. So me of the topics dealt
with are: descriptive statistics, normal and bino mial d istributions, statistical inference and reliability
intervals, non-parametric statistics, linear regression analysis, and statistical aspects of the design and
implementation of research.

Lecturers:         Dr V. Fidler (senior lecturer in Medical Statistics);
                   Drs. J.G.M . Burgerhof (lecturer in Medical Statistics).

Study load: 2 EC.

Period: 2-3 weeks in June.




Information/ Enrol ment
NCG, Ms. R.C. Kroese. Ant. Deusinglaan 1, 9713 A V Gron ingen. Telephone: (050) 363 2868.
E-mail: ncg@med.u mcg.n l




                                                                                                           15
       Education Programme for Post-graduate Students of the Graduate School GUIDE


LABORATOR Y ANIMAL SCIE NCES                                     Centraal Dierenlaboratorium RuG



Aim
Upon complet ion of the course, the participants will receive the licence as defined in article 9 of the
Animal Experiments Act. This licence is required for unsupervised conducting of animal experiments.

Intended for
Scientific staff, post-graduate students, and students of the University of Groningen, provided they
have a degree in one of the biomed ical sciences (Medicine, Veterinary Medicine, Dentistry, Bio logy,
Pharmacy). Individuals with a different degree (e.g. Chemistry or Biochemistry) are to study additional
course materials and pass an entrance examination before they can enrol. On average, preparat ion for
this examination will take 100 to 200 hours, depending on one‘s educational background.

Organisation
The course will take 3 weeks and consists of lectures, seminars, practical classes, and
demonstrations. About 3 days should be set aside for private study. The course will be concluded with
an examination. Part icipants who pass this examination will receiv e the official Article 9 cert ificate.
They will also be entered into the Article 9 register of the Min istry of W VC.

Content
The following topics will be dealt with: the history of animal experiments, legal aspects, genetics,
animal behaviour, stress, animal welfare, statistics, nutrition, anaesthesia, analgesia, euthanasia,
gnotobiotics, pathology, zoology, ethics, etc.

Study load: 3 EC.

Frequency: four t imes a year.




Information/ Enrol ment
Centraal Dieren laboratoriu m, RUG. ms M.H. Overd ijk, Ant. Deusinglaan 50, 9713 AZ Groningen.
Telephone: (050) 363 2631.
E-mail: m.h.overdijk@med.u mcg.nl




                                                                                                         16
       Education Programme for Post-graduate Students of the Graduate School GUIDE


SCIENCE TO THE MARKET                                                                      GUIDE



Aim
Overall aim: The overall aim of the course is to train profess ionals to obtain the knowledge and skills
enabling them to co mmercialise scientific ideas or techniques.
Primary endpoint: The primary endpoint of the program is to equip participants with skills to evaluate
possibilit ies for product development and to decide for co mmercialisation.

Intended for
PhD students, postdocs and other scientific staff.

Organisation
The programme consists of 8 one-day modules with a monthly frequency. The guiding princip le of the
programme is that participants acquire knowledge and skills through functioning as a member of a
mu lti-disciplinary team. Every module is structured in a way that general knowledge on the topic is
gained through team work and homework assignments.

The init ial 3 modules are meant to introduce participants to the programme and to train fundamental
skills (e.g. co mmunication, problem solving, basic economics, value of money, management styles,
decision process, outline of a business plan).
In the remain ing 5 modules the team acquires skills by generating a business plan using an actual idea
or technique of one of the participants. Separate modules deal with specific parts of the business plan,
e.g. patents, market ing, pharmaceutical info rmation and finances.

The teams will be supported by professionals, both from university setting, the world of co mmerce and
banking.

Language: Eng lish.

Frequency
Every t wo years, Spring.




Information and enrol ment
GUIDEo ffice. GUIDE o ffice, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: h.m.m.banus@med.u mcg.nl
Coordinator: Dr. M.H.J. Ru iters, Synvolu x; mhjruiters@synvolux.nl




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


GOOD RESEARCH PRACTICE: GLP/GCP                                                             GUIDE




Aim
The aim o f this course is to increase knowledge on methods to imp rove the integrity and the quality of
(bio)med ical research.

Quality management of drug research will be discussed by introducing the legal requirements of Good
Clin ical Pract ice (GCP), Good Laboratory Practice (GLP) and by discussing the international qua lity
standard ISO-9000.

After having attended this course the PhD students will be able to successfully perfo rm their research
according to the state of the art (legal) quality standards.

Intended for
The course is intended for PhD students who want to perform b io-medical/
bio-pharmaceutical research according to the standards required by the international authorities for
drug registration (―market authorizat ion‖).

Organisation
The course takes 7 days and is a mixture of lectures, site visits to a GCP-cert ified clinical research
centre and a GLP-certified laboratory, demonstrations and case studies.
Participation requires thorough preparation by studying the abstracts and the literature, which will be
provided before the start of the study.

Content
General principles of quality management (applied to drug research); Legal aspects on new drug
development; Good Clin ical Pract ice (GCP) (Protection of Sub jects: preparing, performing and
evaluating a clinical pharmacology (―Phase I‖ study); Good Laboratory P ractice (GLP); Bioanalysis in
the context of new drug develop ment according to GLP; Organizational and Technical Aspects in the
Bioanalytical Laboratory; preparing, performing and evaluating a bioanalytical study; Archiving.

Frequency: once a year (May).
Maximu m nu mber of part icipants: 25

Study load: 3 EC.

Information
Prof.dr J.H.G. Jonkman, e -mail: research@jhgjonkman.n l




Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                          18
       Education Programme for Post-graduate Students of the Graduate School GUIDE


GOOD MANUFACTURING PRACTICE                                                               GUIDE




Aim
Beco ming familiar with modern quality management guidelines and regulations with respect to the
production of drugs and the application of these guidelines in drug development.

Intended for
GUIDE post-graduate students. Open places may be filled by indiv iduals fro m other institutes, research
schools and industry.

Organisation
Lectures, case-studies and practicals.

Study load: 1 EC.

Content
Gain ing insight in the various aspects to the regulations of good manufacturing practice based on Dutch
and European rules (Vo lu me 4) and the impact these regulations have on the actual production of
drugs. On the basis of Annex 13 (Manufacture of investigational med icinal products) important aspects
like docu mentation, the determination of specificat ions, procedures and change control will be
discussed. The various parts of validation will co me up by means of Annex 15.
Conditions as to production and sterilisation will be d iscussed on the basis of Annex 1.
The participants will develop a production process and validate it under GM P to prepare this process
for inspection.

Frequency: once a year. 3 days.




Information
Dr.ir H. van Doorne, Prof.dr H.W. Frijlink, Pharmaceutical Technology, Ant. Deusinglaan 1,
9713 A V Groningen, telephone: (050-)363.3285; 363.3484.

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


APPLICATION OF M ODER N TECHNIQUE S IN LIFE SCIE NCES                                        GUIDE



Aim
Learn about the most recently developed analytical methods and their applications in life science
research.

Intended for
GUIDE post-graduate students. Individuals fro m other institutes, research schools, and industry who
are interested in this topic can also participate.

Organisation
Lectures, practical classes, and site-visits may be part of the course. This will depend on the
educational background and expert ise of the participants.

Content
Technological developments in recent years have had a major influence on how life science research is
performed. Th is trend is likely to continue in the future due to continued technological develop ments
and their applications to med ical and bio logical research questions. Analytical Chemistry, the science
of separating and identifying mo lecules is at the center of these developments. Describing a biological
system in mo lecular terms is now beco ming a reality due to high-throughput and informat ion-rich
analytical methods. Integration and analysis of these huge data sets remains, however, a challenge and
major advances in Bioinfo rmatics are to be expected in the co ming years.
Subjects: Geno mics, Proteomics, Analytical To xicology, Bioanalysis, Clinical Chemistry,
Metabolomics, Bioinformatics.

Study load: 4 EC.




Information
Prof. dr R. Bisschoff, Analytical Chemistry & To xicology, Ant. Deusinglaan 1,
9713 A V Groningen, e-mail: telephone: (050) 363 3336.

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                       20
       Education Programme for Post-graduate Students of the Graduate School GUIDE


WORKING WITH RADIOACTIVE SUBSTA NCES                                                          GUIDE



Aim
Beco ming acquainted with the practice of working with rad ioactive materials in a C laboratory. Upon
complet ion of the course, the participants will be able to work unsupervised in the C lab as part of their
research projects.

Intended for
GUIDE post-graduate students and lab technicians who intend to work with rad ioactive substances as
part of their research.

Organisation
The course will consist of one week of private study of the theory concluded with a multip le -choice
test, followed by one week of pract ical classes. A pass mark for the examination is required for
enrolment in the practical classes.
The practical work will be done in the C laboratory.

Content
The practical classes will include the following topics: procedu res, working safely in the C lab, and
scintigraphy. Possibly, some additional practical experiments with closed radiation sources will be
included in the programme, so that participants become eligib le fo r a 5B cert ificate. The lab wo rk will
be evaluated in terms of skill, mot ivation, and a report written by the participant.

Study load: 2 EC.

Frequency: 4 times a year.

Mi ni mum/ maxi mum number of partici pants: 6/ 12.

Note:
This particular course is part of the Pharmacy curriculu m. GUIDE staff/post -graduates may enrol if
there is room for them. Alternative courses are provided by the Arbo - en Mileudienst (level 5B-3) and
the Chemistry and Biology departments.




Information/ Enrol ment
Secretariat Analytical Chemistry & To xicology, Ant. Deusinglaan 1, 9713 A V Groningen.
telephone: (050) 363 3336.




                                                                                                          21
       Education Programme for Post-graduate Students of the Graduate School GUIDE


WORKING WITH ISOTOPES                                                     Biologisch Centrum R UG


Aim
Learn ing to safely handle radioactive tracer substances and apply them in b iological research, and
gaining an insight into techniques for radiation detection.
The course, including a theoretical and a practical part, is finished by an examination. A positive mark
entitles to the 5b-certificate, which is needed to get a permit to handle radioactive sources.

Intended for
Under-graduate students who want it as part of their scientific t rain ing or need to use radionuclides as
part of their research. The course is also open for graduate students, post -docs. and technicians,
provided there is enough capacity.

Organisation
The theoretical knowledge obtained by self-study and the practical course followed by a mu ltiple -
choice examination, will take 2 weeks.

Content
The following topics will be dealt with : principles of radioactivity, radioactive decay, radiat ion
hazards and protection, dosimetry, scintigraphy, gamma spectrometry, autoradiography, etc.
The practical classes will be devoted to working safely with rad iation sources, measuring various types
of radiat ion, shielding rad iation sources, and applying radioactive substances in biological research.

Study load: 2 EC.

Frequency: 3 times a year (September. January and April).




Information/ Enrol ment
Dr. C.A. Vermeulen, Biologisch Centru m RUG, Kerklaan 30, 9751 NN Haren.
Telephone: (050) 363 2410.
E-mail: C.A. Vermeu len@biol.rug.nl




                                                                                                        22
       Education Programme for Post-graduate Students of the Graduate School GUIDE


MICROBIOLOGICAL SAFETY                                                                       GUIDE




Aim
Learn ing to limit the risk of potentially dangerous bacteria escaping the laboratory.

Organisation
Organised by the Medical Microb iology department. A three-day course (classes usually fro m 09.00 to
12.30 hrs), wh ich will mainly consist of practical work. The course is legally required for those who
intend to use genetic modification, but who are not qualified or do not possess a recognized certificate.

Content
The course pays attention to the following topics: general manual skills and techniques relevant to the
isolation of (potentially) pathogenic micro-o rganisms; extinction rate of bacteria outside a culture;
disinfection and sterilisation; escape by contamination and aerosols; checking for cleanliness; working
in a safety cabinet; applying for a permit fo r genetic modificat ion. So me theoretical background will be
provided as well as a summary of Dutch leg islation on genetic modification.

Study load: 1 EC.

Mi ni mum/ maxi mum number of partici pants: 6/ 15.

Frequency: twice a year: April and October.




Information/enrol ment:
Dr A.J. Scheffer, Medical M icrobiology UM CG, telephone: 050-363 3515.
E-mail: a.j.scheffer@med.u mcg.n l.




                                                                                                         23
       Education Programme for Post-graduate Students of the Graduate School GUIDE


TECHNIQUE S OF MOLECULAR BIOLOGY                                                              GUIDE



Aim
Gain ing an insight into various detection and synthesis techniques in mo lecular b iology.

Intended for
Post-graduate students, scientists, and lab technicians who use or wish to use molecular b iological
techniques in their research.

Organisation
The course will take 3 weeks, usually with classes from 09.00 to 17.00 hrs.
The emphasis will be on lab work, supported by some theoretical background material. At the start of
the day, the experiments and the theory underlying the techniques to be used will be exp lained. In the
afternoon, a lecture will usually be given by a person who works with a particu lar technique or several
techniques as part of his or her job.
Prior to the course, participants are to study various background articles and parts of the Recombinant
DNA textbook by Watson and Gilman. The literature will be sent to the participants approximately one
month before the start of the course. This material will help to even out differences in educational
background between participants.
At the start of the course, the participants will be g iven a folder with more background material,
protocols, assignments, and other information relevant to the course.
Upon complet ion of the course, the participants will receive a certificate.

Content
The following topics will be dealt with: plasmid isolation, gene cloning, blotting techniques, PCR
techniques, in situ hybridisation, DNA sequence analysis, and primer design and synthesis.

Study load: 4 EC.

Number of participants: 8.

Frequency: twice a year (in November and June).




Information
Dr B. Stulp, Pathology & Laboratory Medicine UM CG, section Molecular Biology,
Telephone: 050 363 9528.
E-mail: b.k.stulp@path.azg.nl

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                       24
       Education Programme for Post-graduate Students of the Graduate School GUIDE


BIO-INF ORMATICS                                                                          GUIDE



Aim
Acquainting those who work with mo lecular biological techniques with relevant informat ion
technology, ways to extract relevant information fro m DNA and protein sequences, and use of the
Internet as a means for consulting molecu lar b iological databases.

Intended for
Post-graduate students, lab technicians, students, and post-doctorate researchers who use or wish to use
mo lecular biological techniques. So me basic Windows (95) skills are required.

Organisation
Five periods of 4 hours (practical co mputer classes and lectures).

Content
The following topics will be dealt with:
•   Molecular b iological software for sequence alignments, homo logy research, restriction enzy me
    analysis, pattern/signal recognition in DNA and protein sequences;
•   Design of PCR primers and probes;
•   Molecular b iological databases, genome projects, and search engines;
•   Molecular b iological information on the Internet.

Study load: 1 EC.

Frequency: once a year.

Location: A. Deusinglaan 1, Co mbizaal.

Maxi mum number of partici pants: 14.




Information
Dr P. Terpstra, Pathology & Laboratory Medicine UMCG, section Molecular Biology
(entrance 25), telephone: (050) 363 6669, e -mail: p.terpstra@med.u mcg.nl.

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                      25
       Education Programme for Post-graduate Students of the Graduate School GUIDE


EPIDEMIOLOGY A ND APPLIE D STATISTICS                                                      GUIDE



Aim
To learn about the concepts, princip les, and methods in epidemio logy. The participants will beco me
familiar with study designs, methodological problems, statistical analyses and causal inference. The
skills learned in this course are of importance when practicing (o wn) research as well as when
evaluating published research.

Intended for
Post-graduate students, research fellows and others who are interested.

Organisation
The course takes 3 weeks and will be a mixture of lectures, assignments and practical classes.

Contents
Topics include:
    -    study designs (cross-sectional/ longitudinal, descriptive/experimental, case-
         control/cohort/intervention);
    -    study population;
    -    how to formulate a research question and to make it operational;
    -    how many subjects are necessary to include into your study (power);
    -    measures of frequency: prevalence/incidence, risk d ifference, population attributable risk;
    -    measures of effect: relative risk (RR), odds ratio (OR);
    -    methodological problems : precision/ validity, selection bias/ info rmation bias/ confounding;
    -    possible ways to deal with confounding in the study design (matching, randomisation);
    -    causality;
    -    descriptive statistics (plots, distribution, group differences)
    -    association (correlation, regression);
    -    how to deal with confounding in the analysis (stratificat ion, interaction and effect
         modification);
    -    deriving in ferences (statistical significance, clinical relevance, trend).


Study load: 3 EC.

Frequency: Once a year, November.

Number of participants: 8-12.




Information:
Dr.ir. D.F. Jansen, Dept. of Epidemiology UM CG
Telephone: (050) 363 2861. E-mail: D.Jansen@med.u mcg.nl

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                          26
       Education Programme for Post-graduate Students of the Graduate School GUIDE


ADVANCED IMMUNOLOGY                                                                          GUIDE



Aim
Gain ing a detailed insight into various immunological processes.

Intended for
GUIDE post-graduate students. Open places may be filled by indiv iduals fro m other institutes, research
schools, industry, who are interested in this topic.
Advanced Immunology 1 is mainly intended for participants with some knowledge of immunology.

Organisation
Lectures and private study. This is an existing Immunology course for third and fourth -year students of
Biology and Medicine, lab technicians, post-doctorate researchers, and others interested in the subject.
The course will take 4 weeks. During the first 3 weeks, a three-hour lecture will be g iven each
morn ing. The fourth week is set aside for private study. An examination, co nsisting of essay questions
concludes the course.
Although the participants consider the course to be fairly strenuous, they rate it very highly.

Content
The course presents a rather detailed insight into the organs and elementary cellu lar and mo lecular
processes of the immune system. The textbook used is Abbas, Licht man, and Pober, Cellular and
Molecular Immunology (3rd ed.).

Study load: 4 EC.

Frequency: once a year. April.

Maxi mum number of partici pants: 20.




Information/ Enrol ment
Dr W. Helfrich, Pathology & Laboratory Medicine UM CG, Sect ion Tumo r Immunology.
Telephone: (050) 361 3733. E-mail: w.helfrich@med.u mcg.nl.




                                                                                                        27
       Education Programme for Post-graduate Students of the Graduate School GUIDE


MICROBIOLOGY / INFECTIOUS DISEASE S                                                          GUIDE


Aim
Gain ing an insight into the pathology of infectious diseases. Microbiological d iseases are studied by
various disciplines.The course will include elements fro m several fields, fro m basic to clin ical
microbio logy.
Staff members of various departments will present aspects of infectious diseases from different
perspectives.

Organisation
Lectures, research projects. This is an existing Medical M icrobiology course for the students of
Medical Biology, post-doctorate researchers, and others interested in this subject.
The course will take 4 weeks. During the first two weeks, lectures will be given each morning. An
examination, consisting of essay and multip le choice questions, will be held at the beginning of the
third week. In the third and the fourth week research projects in Medical Microbiology can be
followed. The course fin ishes with a one-day symposium consisting of oral presentations and poster
sessions by the participants. It is possible to follo w the first two weeks only, including examination.

Content
The course will g ive an insight in the background and pathology o f microbial infections.
The textbook used is: Medical Microbiology, by Murray PR, Rosenthal KS, Kobayashi GS and Pfaller
MA (Mosby, London).

Frequency: once a year. February/March.

Study load: either 2 or 4 EC.

Partici pating departments
Medical M icrobiology
Public Health Laboratory
Bio-adhesion




Information/ Enrol ment
Dr S. Welling-Wester, Medical M icrobio logy UMCG.
Telephone: (050) 363 3514/3510; fax: (050) 363 3528. E-mail: s.welling-wester@med.u mcg.nl.




                                                                                                           28
       Education Programme for Post-graduate Students of the Graduate School GUIDE


ADVANCED DR UG DE LIVER Y & DR UG TARGETING                                         GUIDE/ UIPS


A joint effort between the Groningen University Institute of Drug Exploration (GUIDE) and the
Utrecht Institute for Pharmaceutical Sciences (UIPS)


Aim
In recent years, new chemica l and biotechnological co mpounds have entered the stage of preclin ical
and clinical develop ment. Application of such agents that exert potent pharmacologic act ivity is,
however, often hampered by undesirable to xicity or limited effectiveness due to unfavou rable
behaviour in the body. One of the main challenges in drug development is to deliver the drug in a
controlled way at the desired site of action.
Intended for
Researchers (researchers in training, postdoctoral fello ws, research associates, research pro ject
managers) in Un iversities, Pharmaceutical Industry, Biotechnology Industry, and Federal Research
Laboratories, whose research or research interests lie in the area of new technologies facilitating drug
distribution, drug release, and drug effectivenes s.


Organisation
In the Advanced Drug Delivery / Drug Targeting course, experts in the field of
  drug behaviour in the whole organism and in cellu lar systems
  drug transport mechanisms through cell barriers in the body
  construction of drug carriers and drug-carrier conjugates
  application of drug-carrier constructs in disease treatment
 will provide a state-of-the art overview on newest achievements in the respective field of expert ise and
 on the challenges that lie ahead.
 Furthermore, the participants will actively work in groups on assignments in which they will address
 various issues for consideration in the development of therapeutic strategies employing drug delivery
 and drug targeting technologies. On line co mputer facilit ies are available throughout the course for the
 assignments and preparation of the oral presentations that accompany the assignments.

Objecti ve
The objective of the course is to discuss the extended experiences with advanced drug delivery and
drug targeting approaches in relation to the newest developments in this area of drug develop ment.
Through active discussion and interaction between the participants and lecturers, the theoretical
background gets firmly integrated in the way of thinking about diverse subjects related to drug
delivery and drug targeting.

Study Load: 3 EC.

Information
Prof.dr G. Molema, Pathology & Laboratory Medicine. E-mail: g.mo lema@med.u mcg.nl.
Prof.dr D. Cro mmelin, Utrecht Institute for Pharmaceutical Sciences .
E-mail: d.j.a.cro mmelin@pharm.uu.nl




Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                        29
       Education Programme for Post-graduate Students of the Graduate School GUIDE


MEMBRANES, SIGNALING AND TRA NSPORT                                                         GUIDE




Aim
Gain ing an insight into the structure of memb ranes and their function as barriers, the fundamental
processes that determine the distribution and elimination of endogenous compounds and drugs in the
body, and the way in wh ich signal transduction pathways extend along cell membranes.

Intended for
GUIDE post-graduate students and technical staff working in th is field. Individuals fro m other
institutes, research schools, and industry who are interested in this topic may fill open places.

Organisation
Lectures and seminars, private study with tutoring, practical demonstrations.

Content
Recent concepts of mechanis ms of membrane transport — for examp le in the digestive tract
(absorption and secretion) and in the excretory system (eliminat ion by way of the liver and kidneys) —
will be discussed. Reference will be made to the conclusions of recent studies. Drug metabolisation
mechanis ms will also be dealt with. Topics will include:
•   The structure, biogenesis, and dynamics of bio logical membranes;
•   Mechanisms of membrane transport;
•   Mechanisms of signaling pathways by way of memb ranes;
•   Animal experiments and human models;
•   Analytical and image p rocessing techniques;
•   Deviations in drug transport and metabolism;
•   Case studies.

Study load: 3 EC.

Period: Spring.




Information
Dr J.W. Kok, Membrane Cell Bio logy. Telephone: (050) 363 2725. E-mail: j.w.ko k@med.u mcg.n l.

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                       30
       Education Programme for Post-graduate Students of the Graduate School GUIDE


DESIGN, C ONDUCTION A ND EVALUATION OF A CLINICAL TRAIL                                        GUIDE



Aim
This course provides an insight in the area of clinical trials with patients, with more detailed coverage
of trial, analysis and interpretation of phase IIb-IV studies fro m the point of view of clinical research,
industry and government.

Intended for
GUIDE doctoral candidates as well as persons who are involved in clinical trials fro m other institutes,
research schools, industry, and government agencies.

Organisation
The course is organized in collaboration with the Clinical Pharmacolo gy, TCC (Trial & Coord ination
Centre) and Pharma Bio Research. The course is based on interactive exercises and will be presented
by means of capita selecta and practica within the framework o f their own to be designed clinical trial.

Content
The course faculty will review important information regard ing the practical issues in the design of
clin ical trials and protocol development, as well as broader issues related to the initiation and
conduction of clin ical trials and the analyses and interpretation of clinical trial data.
Students will learn :
-     Basic statistical concepts, like descriptive statistics, hypothesis testing, estimat ion, confidence
      intervals, different statistical tests, etc. Bio medical applications are discussed for each topic.
-     Fundamentals of clinical trial design. Topics include e.g. definit ion of hypotheses, measures of
      effectiveness, sample size, rando mizat ion, interim analysis, safety considerations and issues in
      statistical analysis.
-     Ethical and regulatory issues in the design, conduct and reporting of research will be examined.
      Topics include e.g. GCP, informed consent, patient information, and institutional review boards.
-     Coordinating of clinical trials – issues will be addressed in the operation of coordinating a clinical
      trial. It covers organizational aspects, forms design and collection, quality control and other
      operational methods to improve the quality of data.

Study Load: 3 EC.

Frequency: Once a year. Spring.




Information:
Dr H. Hillege, TCC/UM CG. Telephone: 361 8066/ 8061
h.hillege@tcc.u mcg.nl
Prof.dr W.H. van Gilst, Klin ische Farmacologie UM CG. Telephone: 363 2810/ 2811

Enrol ment
GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




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       Education Programme for Post-graduate Students of the Graduate School GUIDE


PHARMACOEPIDEMIOLOGY & DRUG POLIC Y                                                GUIDE/UIPS

A joint effort between the Groningen University Institute of Drug Exploration (GUIDE) and the
Utrecht Institute for Pharmaceutical Sciences (UIPS)



Objecti ves
To understand principles and research methodology of pharmaocoepidemiology and health services
research. The participants will become familiar with specific techniques to determine the use of
(exposure to) drugs, with research in determinants of drug use and strategies to change/improve use
and how to relate exposure to drugs to relevant outcome (effects, side effects, quality of life, economic
measures).

Partici pants
PhD students and other research fellows preparing an PhD thesis within the research school GUIDE, as
well as others fro m the pharmaceutical sector with an interest in the field of pharmacoepidemio logy
and drug policy.

Organisation
The course will be using seminars, case studies and self-study.

Study load: 2 EC.

Evaluati on: The evaluation is based on realisation and presentation of assignments.

Frequency: Once every t wo years.

Location: The course will be o rganised both in Utrecht and in Groningen.




Information/ Enrol ment
Prof.dr L.T.W. de Jong-van den Berg, Dept. of Pharmacoepidemiology and Drug Po licy.
Telephone: (050) 363 3330 E-mail: l.t.w.de jong-van den berg@rug.nl;.
Prof.dr F.M. Haaijer-Ruskamp, Dept. Of Clinical Pharmacology. Telephone: (050) 363 3216/2810.
E-mail: f.m.haaijer-ruskamp@med.u mcg.nl.

GUIDE office, Ant. Deusinglaan 1, 9713 A V Groningen. Bldng 3217 ―De Brug‖.
Telephone: (050) 363 8409; fax: (050) 363 2612.
E-mail: m.h.bansema@med.u mcg.n l




                                                                                                       32
      Education Programme for Post-graduate Students of the Graduate School GUIDE




GUIDE Graduate School - 2006 -




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