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| Download Programme 2018 (PDF) | ||
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Monday March 12, 2018 |
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| Subject | New Drug Development; Good Research Practices: Good Clinical Practices: Introduction | |
| Organization | GUIDE Graduate School for Drug Exploration University of Groningen |
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| Responsible teacher |
Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph. Web: www.pharmadvices.com |
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| Building/Room | University of Groningen Medische Wetenschappen, Farmacie, Tandheelkunde en Bewegingswetenschappen Antonius Deusinglaan 1 Building: 3215 Room : 0149 NL - 9713 AV GRONINGEN |
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| 09:00 - 10:00 |
Welcome Introduction of the participants Introduction on the Course Leader Introduction on the Course |
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| 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.) |
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| 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.) |
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| 11:45 - 11:50 | Video | |
| 11:50 - 12:35 | Marketing Authorization Procedures (L. Vromans, MA) |
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| 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.) |
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| 15:00 - 15:15 | Introduction on the Case Studies | |
| 15:15 - end | Preparation of Case Studies (Home work) | |
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Tuesday March 13, 2018 |
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| 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 |
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| 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.) |
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| 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.) |
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| 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.) |
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| 12:45 - 13:45 | Medical Research with Human Subjects in The Netherlands; The Role of Medical Research Ethics Committies (Prof. G.H. Koëter, Former Chairman of CCMO, Centrale Commissie Mensgebonden Onderzoek) |
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| 13:45 - end | Preparation of Case Studies (Home work) | |
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Wednesday March 14, 2018 |
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| 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 |
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| 09:00 - 10:00 |
Responsibilities of the Sponsor Clinical Drug Research R. van Olden, M.D.: Horizon Pharma) |
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| 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.) |
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| 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.) |
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| 12:15 - end | Preparation of Case Studies (Home work) | |
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Thursday March 15, 2018 |
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| 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 |
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| 14:00 - end | Preparation of Case Studies (Home work) | |
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Friday March 16, 2018 |
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Subject |
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Good Research Practices and Quality Management: Theory |
| Building/Room |
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University of 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.) |
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| 10:15 - 10:30 | Break | |
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| 10:30 - 11:00 |
Standard Operating Procedures (SOP’s) (Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.) |
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| 11:00 - 11:30 |
Document Management and Archiving (Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.) |
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| 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.) |
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| 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.) |
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Monday March 19, 2018 |
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| 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 |
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| 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) |
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| 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) |
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| 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) |
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| 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.) |
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| 14:30 - 14:45 | Video - Research Integrity (Ben Goldacre, M.D.) | |
| 14:45 - end | Preparation of Case Studies (Home work) | |
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Tuesday March 20, 2018 |
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| 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 |
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| 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.) |
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| 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.) |
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| 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) |
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| 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 |
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| 09:00 - 10:00 |
Performing a Bioanalytical Study (Part I) (Marion Kranenborg, QPS Netherlands B.V.) |
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| 10:00 - 10:15 | Break | |
| 10:15 - 10:45 | Performing a Bioanalytical Study (Part II) (Marion Kranenborg, QPS Netherlands B.V.) |
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| 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 |
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| 13:30 - end | Preparation of Case Studies (Home work) | |
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Thursday March 22, 2018 |
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| Subject | Case Studies | |
| (Presentations by the participants on the course) Discussion |
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| Building/Room | University of Groningen Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen Antonius Deusinglaan 1 Building: 3215 Room : 0149 NL - 9713 AV GRONINGEN |
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| 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 | |
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Friday March 23, 2018 |
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| Subject | Case Studies | |
| (Presentations by the participants on the course) Discussion |
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| Building/Room | University of Groningen Medische Wetenschappen en Farmacie, Tandheelkunde en Bewegingswetenschappen Antonius Deusinglaan 1 Building: 3215 Room : 0149 NL - 9713 AV GRONINGEN |
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| 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 | |