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? N.N. (Investigator), Biokinetica, Poland
09:40	What does a Regulator authorizing an early phase clinical trial need from an Investigator’s Brochure? N.N. (invited)
10:10	What are the challenges of pre-clinical and translational experts in interpreting, risk-assessing and explaining the so far existing results? Daniela Arndt, 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. Stephanie Plassmann, PCS, Switzerland; N.N. (invited) 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. Henri Caplain, France; Nariné Baririan, Chiesi, Italy 3. Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries. Sandrine Tinton, AFMPS, Belgium; N.N. BfArM (invited) 4. Investigator / end-user Aspects: e.g., needs for interpreting safety of participants, difference early / late phase investigators. Yves Donazzolo, Eurofins Optimed, France; Jeroen van Smeden, CHDR, The Netherlands;N.N. late phase investigator Poland (invited)
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. Stephanie Plassmann, PCS, Switzerland; N.N. (invited) 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. Henri Caplain, France; Nariné Baririan, Chiesi, Italy 3. Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries. Sandrine Tinton, AFMPS, Belgium; N.N. BfArM (invited) 4. Investigator / end-user Aspects: e.g., needs for interpreting safety of participants, difference early / late phase investigators. Yves Donazzolo, Eurofins Optimed, France; Jeroen van Smeden, CHDR, The Netherlands;N.N. late phase investigator Poland (invited)
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