SEMINAR: The Impact of ICH E6 R3 on Medical writing documents (not for credit)

Description

ICH E6(R3): How Does it Impact Medical Writing Documents?
The third revision of the International Council for Harmonisation (ICH) E6 guideline on Good Clinical Practice (GCP) was released on 6 Jan 2025. It became effective in the EU on 23 Jul 2025. On a high level, ICH E6(R3) brings significant updates to the global standard for clinical trials, promoting a more flexible, risk-based, and technologically advanced approach to clinical research while ensuring the protection of trial participants. But what does it mean for clinical trial documents that medical writers are responsible for? This seminar will provide a summary of the key updates and highlight the changes with the most relevance for medical writers, especially those impacting the study protocol and the investigator’s brochure.

We will be joined by EMWA experts on GCP who provide different perspectives:

Sarah Hopwood (Veristat), from the perspective of CROs and service providers
Heather Mason (EUPATI)/Sarah Milner (Incyte), from the perspective of patients, with focus on vulnerable populations
Uma Swaminahtan (GSK), from the bioethics perspective
Moderated by Jules Kovacevic (Ambermed)