In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3

About this session

Session: RBQM IN A CHANGING REGULATORY LANDSCAPE

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.

Speaker

• AL

  Arlene Lee

  Director · Medidata

  Speaker