Talk Quality & Monitoring track
In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3
Tue, Feb 4, 2025 · 11:30–11:55 AM EST Rosen Shingle Creek
About this session
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) renovation of Good Clinical Practice (GCP) represents a philosophical shift in the conduct of clinical research away from a one-size-fits-all approach to a more pro-active, risk based approach. RBQM is the bedrock of drug development excellence: our goal is to enhance understanding and increase implementation of key topics detailed in ICH E6 R3. After soliciting direct feedback from our respective member companies, ACRO and TransCelerate have developed a set of tools to support the implementation of a strong foundation for quality in clinical development.
