Back to Agenda
Session 6: Consensus Organizations
Session Chair(s)
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
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.
Have an account?