A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available.
Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI shared background on ICH E6 and the plan to engage with stakeholders to inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Multiple stakeholders then shared their experiences with ICH E6(R2). Overall, the web conference was a testament to the importance of having engagement at the heart of the development of E6.
View the slide decks for each day of the web conference to learn more from each presenter.
For additional information on the ICH E6 revision efforts, please refer to the following materials: