Veterinary Faculty Munich (LMU)1 / EMEA2 / CVMP3 / FEDESA4

Workshop
Good Clinical Practice (GCP) for the Conduct of Clinical Trials for Veterinary Medicinal Products
Munich, 17 – 18 September 2001
17 September 2001
Chair of the meeting
R. Schulz , Veterinary Faculty Munich (LMU), Pharmacology Department
S. Dean , CVMP/ EMEA
13.30 Registration of participants
14.00            Welcome and Opening of the meeting
M. Stangassinger, Dean of the Veterinary Faculty Munich (LMU)
14.15 Introduction to the Workshop
S. Dean, EMEA/CVMP
14.30         Update on VICH
S. Zänker, FEDESA
14.50 Introduction to the VICH GCP GL: History and Background
L. Kaartinen, CVMP
15.05 Field of application of the guidelines (efficacy/tolerability studies, dose titration vs. dose confirmation, laboratory vs. field studies)  
V. Cracknell, Pfizer
15.35 Questions and Discussion
16.00 Coffee break  
16.20         Comparison of VICH GLs vs. current EU GLs (Specific changes and practical implications in regulatory requirements with the new VICH GL for sponsor, monitor, investigator)
M. Pott, Cadport Consultancy  
16.40        

Responsibilities for documentation, data management, product management
J. Luker, Elanco (unable to attend) was presented by V. Cracknell

17.00 Questions and Discussion  
17.30 Introduction to the Breakout sessions of next day
S. Zänker, FEDESA
19.15 Reception  
20.00 Dinner  
18 September 2001
Chair of the meeting
J. Steffan , Novartis & K. Hellmann , Klifovet
08.30 Videotape on the role of investigators of clinical trials*  
09.00 Expertise required for monitors, investigators and Contract Research Organisations  
K. Hellmann, Klifovet
09.20 Investigator: Today’s role/contribution of a veterinary faculty in clinical trials
K. Pfister, Veterinary Faculty Munich (LMU)
09.40 GCP and Quality Assurance
K. Krieger, Bayer
10.00 Specific aspects on GCP related to vaccines
T. Nell, Intervet
10.20         Questions
10.40 Coffee break  
10.50 Start of breakout sessions  
13.00            Lunch *  
14.00 Presentation of the outcome of each breakout session by the rapporteurs:
- Session 1
- Session 2
- Session 3
14.40
Discussion
15.00
Case study: presentation and discussion
N. Tawiah, Pharmacia
15.25 Status of harmonization within regulatory authorities (world-wide) and mutual acceptance of study results generated in different regions/continents: how will the process be monitored and regulated
R. Kroker, BgVV
15.50 Key changes in GCP in the US and Japan
M.P. Lefay, ICON (replaced L. Vickers unable to attend)
16.10 Questions and Discussion  
16.30 Closure of the meeting and coffee  

*Video Tape on the role of Investigators in GCP will be viewed several times (duration: +/- 15 min)

  1. LMU Ludwigs-Maximilians-Universität München
  2. EMEA European Agency for the Evaluation of Medicinal Products
  3. CVMP Committee for Veterinary Medicinal Products
  4. FEDESA European Federation of Animal Health
  5. VMRFG Veterinary Mutual Recognition Facilitating Group

Download the order form for the GCP Handbook and the VICH Guideline


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