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FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections
Session Chair(s)
Cynthia Kleppinger, MD
Senior Medical Officer, Office of Scientific Investigations, OC, CDER
FDA, United States
This session will provide updates about the FDA’s international collaborative inspection initiatives with the EMA and cooperative exchanges with the WHO. Included will be discussions of the FDA-EMA GCP initiative, the new BE initiative and information exchange regarding pharmacovigilance.
Learning Objective : Describe the activities of the FDA-EMA GCP and BE Initiatives; Describe the inspectional collaborations of both regulatory agencies with the WHO; List the types of information that are exchanged in the FDA-EMA collaborations; Discuss how FDA, EMA and WHO use inspectional information shared during the collaborative initiatives and cooperative exchanges.
Speaker(s)
FDA Point of View
Cynthia Kleppinger, MD
FDA, United States
Senior Medical Officer, Office of Scientific Investigations, OC, CDER
EMA Point of View
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
WHO Point of View
Lembit Rago, DrMed, MD, PhD
Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Secretary General
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