EUFEMED Workshop "Making the Investigator's Brochure truly fit for purpose in early medicines development"

The primary objective of the Investigator’s 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. The PI’s need to fully understand the implications of the translational study results in order to decide on the required risk mitigation steps to be taken in the interest of participant protection, is not reliably implemented in the current practice.

Help us to create a more meaningful IB process for translational results interpretation, investigator-centred presentation and decision-making in this Workshop on developing the IB in line with all existing and upcoming international requirements but focusing on the needs in early phase trials. Based on the results from this Workshop EUFEMED will prepare a guideline for public consultation and final publication.

In the final discussion the opinions of the participants will be collected in anonymized polls.

09:00 Welcome and Introduction
09:10 What does the PI of an early phase clinical trial need from an Investigator’s Brochure?
09:40 What does a Regulator authorizing an early phase clinical trial need from an Investigator’s Brochure? 
10:10 What are the challenges of pre-clinical and translational experts in interpreting, risk-assessing and explaining the so far existing results? 
11:00 Breakout sessions I
13:00 Breakout sessions II 
14:00 Reports with discussion from the Break-out Sessions 
15:45 Discussion and decision on concluding recommendations for the early phase IB guideline