In our regulatory world in pharmaceutical manufacturing, we encounter 48 different pharmacopoeias and 20 different sets of GMP globally basically regulating the same work. Harmonization or reliance has long been the holy grail but progress has been at a glacial pace. In this session we will listen to an area where reliance has yielded results, and an area where progress has not been as rapid.
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA
Jaap Venema, PhD, EVP & CSO, United States Pharmacopeia (USP)
David Churchward, Deputy Unite Manager, Inspectorate Strategy and Innovation, MHRA
FDA Representative, Invited