Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

This session will provide an overview of consensus organizations, their ways of working, and key guidelines impacting product safety. The focus will be on Council for International Organizations of Medical Sciences (CIOMS) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) with an introduction to the impact of ISO, HL7, and CDISC standards on regulatory requirements.