ICH-GCP(R3)Revision: Webinar PLUS Workshop

ICH-GCP(R3): Follow-up Workshop - 18 September 2025

In June 2025, participants had the opportunity to learn directly from ICH E6(R3) Expert Working Group representatives Gabriele Schwarz (BfArM, EC/EU representative) and Rebecca Stanbrook (EFPIA Topic Lead). The session provided a comprehensive overview of the extensive revision of the ICH E6 Guideline, covering its new structure, principles, and annexes. Key updates included the flexible risk-based framework, expanded expectations for investigators and sponsors, quality-by-design in trial design, and strengthened requirements around data governance, computerized systems, and essential records.

To build on this foundation, a virtual workshop will now address the practical challenges of implementing ICH-GCP(R3) in clinical trials. Through interactive discussions and case-based insights, participants will explore how to translate the revised guideline into daily operations and manage the most critical changes in practice.

Speakers

• Dr. Ingrid Klingmann, MD, PhD (PharmaTrain, Belgium)
• Elisabeth Reus (Swiss Tropical and Public Health Institute, Switzerland)

This workshop is designed for sponsors, investigators, and clinical research professionals who want to move from understanding the revision to successfully implementing it in their trials.