The ICH E6(R3) draft guideline for Good Clinical Practice (GCP), the global standard for clinical trial conduct, is anticipated to be finalized in the fall of 2024. While this update has many clinical trial sponsors reeling, there is still time to prepare before the guideline is finalized.

“Preparing for GCP E6(R3) Impacts on Regulatory, Clinical, and Quality,” you’ll learn: 

• Overview of ICH GCP E6(R3) changes
• Key considerations across regulatory, clinical, and quality
• Insight into assessing your clinical trial(s) status
• How to prepare now for downstream impacts to ensure guidance compliance

Speakers:

• Elizabeth Bodi, Principal Consultant, Organizational & Quality Solutions, Halloran
• Laura Gilliam, Lead Consultant, Organizational & Quality Solutions, Halloran
• Mamta Puri-Lechner, Senior Consultant, Regulatory Affairs, Halloran
• Meaghan Powers, Associate Principal Consultant, Clinical Development and Operations, Halloran

Register

12:00 PM Eastern Daylight Time