Healixia workshop: How to read and implement the Investigator Brochure (IB)
Designed as a practical afternoon session with lunch beforehand, this workshop will combine expert introductions on regulations, protocol integration and risk analysis with a hands-on group exercise using two real-life case examples.
12:00 – 13:00 | Lunch and welcome
13:00 – 13:20 | Guidelines and regulations
Introduction to the regulatory framework and key expectations for the Investigator’s Brochure (IB).
Speaker: Walter Janssens
13:20 – 13:40 | Integration into a protocol
How the IB is translated into protocol design and operational study considerations, from a sponsor/consultancy perspective.
Speaker: Thomas Lodeweyckx
13:40 – 14:00 | Risk analysis
An investigator perspective on identifying, interpreting and managing relevant risks described in the IB.
14:00 – 15:30 | Hands-on workshop exercise
Participants will be divided into four subgroups, with two groups working on each of the two selected Investigator’s Brochures circulated in advance. The exercise will focus on how to read, interpret and apply the information in practice, using targeted discussion questions prepared beforehand.
15:30 – 16:00 | Lessons learned
Plenary feedback session to review the key observations, reflections and practical takeaways from each subgroup.
16:00 | Conclusion and close