Download Programme 2018 (PDF)
     

 

Monday March 12, 2018

   
Subject   New Drug Development; Good Research Practices: Good Clinical Practices: Introduction
     
Organization   GUIDE
Graduate School for Drug Exploration University of Groningen
     
Responsible teacher  

Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.
Professor em., Quality Management in Drug Research and Manufacturing
University of Groningen
PharmAdvices
P.O. Box 10
NL-7920 AA ZUIDWOLDE
The Netherlands
Phone : +31 523 649 113
Mobile : +31 65 11 98 224
Fax: +31 523649151
Email: research@jhgjonkman.nl

Web: www.pharmadvices.com

     
Building/Room   University of Groningen
Medische Wetenschappen, Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room : 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00


 
  Welcome
Introduction of the participants
Introduction on the Course Leader
Introduction on the Course
     
10:00 - 10:15   Introduction on New Drug Development (Part I)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
10:15 - 10:30   Break
     
10:30 - 11:45   Introduction on New Drug Development (Part II)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
11:45 - 11:50   Video
     
11:50 - 12:35   Marketing Authorization Procedures
(L. Vromans, MA)
     
12:35 - 13:05   Video - Big pharma and 21st Century drug development (Prof. Dr. Chas Bountra)
     
13:05 - 14:00   Lunch
     
14:00 - 15:00   Good Research Practices: GCP (Part I)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
15:00 - 15:15   Introduction on the Case Studies
     
15:15 - end   Preparation of Case Studies (Home work)
     

 

Tuesday March 13, 2018

   
Subject   Good Clinical Practices: Theory
     
Building/Room   University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room : 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00   Good Research Practices: GCP (Part II)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
10:00 - 10:15   Break
     
10:15 - 10:45   Video - The Belmont Report: Basic Ethical Principles and their Application (U.S. Department of Health & Human Services); Office for Human Research Protections)
     
10:45 - 12:00   Good Clinical Practices: the European Directive and Regulation (Part I)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
12:00 - 12:15   Break
     
12:15 - 12:45
 
  Good Clinical Practices: the European Directives (Part II)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
12:45 - 13:45   Medical Research with Human Subjects in The Netherlands; The Role of Medical Research Ethics Committies
‚Äč(Prof. G.H. Koëter, Former Chairman of CCMO, Centrale Commissie Mensgebonden Onderzoek)
     
13:45 - end   Preparation of Case Studies (Home work)

 

 

 

 

Wednesday March 14, 2018

   
Subject   Good Clinical Practices: Theory
     
Building/Room




 
  University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room: 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00
 
  Responsibilities of the Sponsor Clinical Drug Research
R. van Olden, M.D.: Horizon Pharma)
     
10:00 - 10:15   Break
     
10:15 - 11:15
 
  The Responsibility of the Investigator for a Safe Conduct of Clinical Trials (Part I)
(Th. van Iersel, M.D., PRA International B.V.)
     
11:15 - 12:15
 
  The Responsibility of the Investigator for a Safe Conduct of Clinical Trials (Part II)
(Th. van Iersel, M.D., PRA International B.V.)
     
12:15 - end   Preparation of Case Studies (Home work)
     

 

Thursday March 15, 2018

   
Subject   Good Clinical Practices: Practice
     
09:00 - 14:00   Excursion to the Clinical Research Centre of QPS Netherlands B.V., Groningen
Hanzeplein 1
Entrance 53
University Medical Center
NL-9713 GZ GRONINGEN
Contact person: Dr. W. Tamminga
Phone: +31 50 3048000
     
14:00 - end   Preparation of Case Studies (Home work)

 

Friday March 16, 2018

   

Subject

 

Good Research Practices and Quality Management: Theory

     
Building/Room




 

 

University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room: 0149
NL - 9713 AV GRONINGEN

     
09:00 - 10:15
 
  Quality Management in Drug Research
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)

 

   
10:15 - 10:30   Break

 

 

 

10:30 - 11:00
 
  Standard Operating Procedures (SOP’s)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
11:00 - 11:30
 
  Document Management and Archiving
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
11:30 - 12:00   Practical Approaches to Implement GxP's
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
12:00 - 12:45   Lunch
     
12:45 - 13:45   Quality Assurance Audits by Sponsors
(Henk W. Visscher, M. Ph. Sc., M. M. Sc.,
Associate Director Clinical Quality Assurance, Astellas Pharma Europe B.V.)
     

 

Monday March 19, 2018

   
     
Subject   Good Clinical Practices: Compliance
     
Building/Room   University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room : 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00

 
  Computer System Validation in Clinical Research
(Jean-Paul Eycken, M.Sc., M.B.A.
Director FormaliS SA, Diekirch, G-D Luxembourg)
     
10:00 - 10:15   Break
     
10:15 - 11:30   How to Mislead Inspectors during an Inspection?
(Jean-Paul Eycken, M.S.c., M.B.A.
Director, FormaliS SA, Diekirch, G-D Luxembourg)
     
11:30 - 12:45   Compliance with Good Clinical Practices: Inspections in The Netherlands, Europe and Third Countries
(W.R. Verweij, Ph.D.,
Dutch Health Care Inspectorate
Senior Inspector Clinical Trials Ministry of Health, Welfare and Sport)
     
12:45 - 13:30   Lunch
     
13:30 - 14:30   Misconduct in Biomedical Research
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.)
     
14:30 - 14:45   Video - Research Integrity (Ben Goldacre, M.D.)
     
14:45 - end   Preparation of Case Studies (Home work)
     

 

Tuesday March 20, 2018

   
Subject   Good Laboratory Practices: Theory and Compliance
     
Building/Room   University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room: 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00   Good Research Practices: GLP (Part I)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R. Ph.)
     
10:00 - 10:15   Break
     
10:15 - 11:00   Good Research Practices: GLP (Part II)
(Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R. Ph.)
     
11:00 - 11:30   Video GLP
     
11:30 - 11:45   Break
     
11:45 - 13:15
 
  Good Laboratory Practice
(Th. Helder, M. Sc., Former Head of the GLP Monitoring Program in The Netherlands)
     
13:15 - end   Preparation of Case Studies (Home work)
     
Wednesday March 21, 2018    
Subject   Good Laboratory Practices: Theory and Practice
     
Building/Room




 
  University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room: 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00
 
  Performing a Bioanalytical Study (Part I)
(Marion Kranenborg, QPS Netherlands B.V.)
     
10:00 - 10:15   Break
     
10:15 - 10:45   Performing a Bioanalytical Study (Part II)
(Marion Kranenborg, QPS Netherlands B.V.)
     
11:00 - 13:30   Excursion to the Bioanalytical Laboratories of QPS Netherlands B.V., Groningen
Prof. Rankestraat 42
NL-9713 GZ GRONINGEN
Contact person: Marion Kranenborg
Phone: +31 50 3048003
     
13:30 - end   Preparation of Case Studies (Home work)
     

 

Thursday March 22, 2018

   
Subject   Case Studies
    (Presentations by the participants on the course)
Discussion
     
Building/Room   University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room : 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00   Case Study 1
     
10:00 - 10:15   Break
     
10:15 - 11:15   Case Study 2
     
11:15 - 11:30   Break
     
11:30 - 12:30   Case Study 3
     
     

Friday March 23, 2018

   
Subject   Case Studies
    (Presentations by the participants on the course)
Discussion
     
Building/Room   University of Groningen
Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen
Antonius Deusinglaan 1
Building: 3215
Room : 0149
NL - 9713 AV GRONINGEN
     
09:00 - 10:00   Case Study 4
     
10:00 - 10:15   Break
     
10:15 - 11:15   Case Study 5
     
11:15 - 11:30   Break
     
11:30 - 12:30   Case Study 6
     
12:30 - 13:00   Final discussion; Filling out Evaluation Forms
     
13:00   End of course