Talk Global Insights track
S0411 - ICH Townhall
Tue, Mar 18, 2025 · 3:10–4:20 PM CET Singapore Room, Congress Center Basel
About this session
This session will provide an in-depth introduction to the ICH organisation and how it works, including the guideline development process and major opportunities for public input, training resources readily available, and other topics. This session will highlight the recent developments of the ICH E6 Good Clinical Practice (GCP) Guideline revision which is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.
Programme:
- 2. GCP: Patients in focus – Renovation of ICH GCP E6(R3) — Peter Twomey
- 3. ICH Guideline E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials — Julia Djonova
- 4. Pharmacutical Quality Knowledge Management (PQ KM) ICH Technology Platform? — Pär Tellner
- 1. Setting the scene — Gabriela Zenhaeusern, Lenita Lindström
Speakers
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Former ICH Assembly Chair and Senior Expert, European Commission · European Commission
Chair
