Location: University of Warsaw
Faculty of Applied Linguistics
Dobra 55
00-312 Warsaw, Poland
Date: Friday, September 20, 2024 | 9:00 – 16:30
The primary objective of the Investigator Brochure (IB) in a Phase 1 trial is to serve the responsible investigator for reliable benefit-risk assessment, however experience teaches us that it is mostly viewed and written as a Clinical Trial Authorisation document.
Help us to create a more meaningful IB process for translational results’ interpretation, investigator-centred presentation and decision-making.
Block your agenda for this interactive EUFEMED workshop in Warsaw on 20 September 2024!
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Agenda:
| 08:00 | Registrations |
| 09:00 | Welcome and Introduction Jan de Hoon, UZ Leuven, Belgium |
| 09:10 | What does the PI of an early phase clinical trial need from an Investigator’s Brochure? Jeroen van Smeden, CHDR, The Netherlands |
| 09:40 | What does a Regulator authorizing an early phase clinical trial need from an Investigator’s Brochure? Sandrine Tinton, AFMPS, Belgium |
| 10:10 | What are the challenges of pre-clinical and translational experts in interpreting, risk-assessing and explaining the so far existing results? Daniela Guckelberger, PCS, Switzerland |
| 10:40 | Coffee Break |
| 11:00 | Break-out sessions 1
1. Preclinical Aspects: e.g., what data need to be included, how to present this data, risk benefit for first-in-human. 2. Clinical / life cycle IBs: e.g., update of IB during drug cycle, how to keep the IB understandable and ´short´, updates of risk-benefit, substantial amendments. 3. Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries. |
| 12:15 | Lunch Break |
| 13:00 | Break-out sessions 2
1. Preclinical Aspects: e.g., what data need to be included, how to present this data, risk benefit for first-in-human. 2. Clinical / life cycle IBs: e.g., update of IB during drug cycle, how to keep the IB understandable and ´short´, updates of risk-benefit, substantial amendments. 3. Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries. |
| 14:00 | Reports with discussion from the Break-out Sessions Moderator: Ingrid Klingmann, Pharmaplex, Belgium |
| 15:30 | Coffee Break |
| 15:45 | Discussion and decision on concluding recommendations for the early phase IB guideline Moderator: Jelle Klein, SGS, Belgium |
| 16:30 | End of the Workshop |