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Center for Human Drug Research

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Presentation on theme: "Center for Human Drug Research"— Presentation transcript:

1 Center for Human Drug Research
On-campus extended course Clinical Development Center for Human Drug Research

2 Paul Janssen Futurelab Leiden
On-campus extended course Clinical Development Course participant Mentor(s) Armida Fabius Pierre Peeters & Rob Zuiker & Kirsty van Nierop Marcel Kenter & Koos Burggraaf & Marjolein Kroonen Gabriël Jacobs & Adam Cohen & Martine Lamfers Matthijs Moerland Mathilde Kouwenhoven Geert Jan Groeneveld Meta Roestenberg Robert Rissmann Sander van Asbeck Adam Cohen Marieke Pierik Koos Burggraaf & Saco de Visser & Paul Janssen Futurelab Leiden

3 Program Friday September 15, 2017
Time Subject Discussion leader/ contribution Where 08:30 – 08:40 Opening & introduction Adam Cohen /Marcel Kenter + Mentors Auditorium 08:40 – 09:05 Presentation by participant #1 incl. 10 min discussion 09:05 – 09:30 Presentation by participant #2 incl. 10 min discussion 09:30 – 09:55 Presentation by participant #3 incl. 10 min discussion 09:55 – 10:20 Presentation by participant #4 incl. 10 min discussion 10:20 – 10:40 Coffee/tea break Cafeteria 11:40 – 11:05 Presentation by participant #5 incl. 10 min discussion Adam Cohen /Mentors Auditorium 11:05 – 11:30 Presentation by participant #6 incl. 10 min discussion 11:30 – 11:55 Presentation by participant #7 incl. 10 min discussion 11:55 – 12:20 Presentation by participant #8 incl. 10 min discussion 12:20 – 13:00 Wrap-up and matching mentors & participants 13:00 – 14:00 Lunch Cafeteria 14:00 – 15:00 Presentation alumnus Ruud Verstegen to be announced Auditorium 15:00 – 15:15 Short tour in CHDR to be announced CHDR 15:15 – 17:30 Individual work on clinical protocol Meeting room C & D Send draft clinical protocol to your mentor(s) before Sunday 19:00 CET

4 CCMO template research protocol & structured risk analysis
The research protocol must contain an introductory section explaining why the research is to be carried out. The scientific and social relevance of the project should be indicated with references to: Peer reviewed papers published in scientific journals (an overview of the references can be given in chapter 14). The results of any pre-clinical studies with potential clinical significance and of any clinical trials or studies relevant to the proposed research should be summarized. Convincing arguments should be given that there is not sufficient knowledge available to explain the problem or for the need to test what is known. It should be clearly stated which new information this study may add to what we already know. This section should also explain why the research needs to be conducted with the selected population. This is particularly important where minors or incapacitated adults are to be used as subjects.

5 Paul Janssen Futurelab Leiden
CCMO template research protocol & structured risk analysis the Lancet 2006, 368: Paul Janssen Futurelab Leiden

6 Paul Janssen Futurelab Leiden
On-campus extended course Clinical Development Wifi code Netwerk: FutureLab Wachtwoord: welkombijfuturelab Netwerk: CHDR Guests Wachtwoord: Welkom01 Paul Janssen Futurelab Leiden


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