Webinar: IB for an early phase/FIH trial: more than just a regulatory document
Speakers: Nariné Baririan and Katrien Lemmens (SGS)
The IB (Investigator's Brochure) is a multidisciplinary document that summarizes the main elements of an IMP’s entire development program to date. The IB is first required when conducting the FIH trial, however, it is a living document and should be updated regularly and when required.
The IB serves to enable investigators and regulators to assess the benefit-risk of a proposed trial, hence, being a mandatory document for CTA and basis of some other documents needed for regulatory interactions.
This online workshop will discuss the IB structure, content and quality as important topics for all parties involved in planning, set-up, conduct and interpretation of a clinical study. Some practical highlights will be shared on challenges on writing a “good” IB for a FIH/Early Phase trial on the one hand, and on how to use it for an optimal benefit-risk assessment on the other hand. The latter being essential to safeguard the participants in clinical trials.
15h00 - Introduction by Erik Mannaert
15h05 - IB for a FIH trial: content, role and challenges by Nariné Baririan
15h45 - How to use the IB to de-risk your FIH by Katrien Lemmens
16h15 - Q&A session
This is the first of two webinars. Register for both now and get a reduction as a non-member (both webinars are free for Healixia members).
Next webinar: September 9, 2022 at 15h00 - 'How to use the IB in de-risking FiH study'.