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Pharmacovigilance Inspections: Achieving Compliance in a Global Environment
Session Chair(s)
Anabela Marcal, PharmD
EMA Liaison Official to the US FDA
European Medicines Agency, Netherlands
The session will provide an overview on the coordination of pharmacovigilance inspections in the EU and the US (including pharmacovigilance inspection metrics). There will be an opportunity to discuss common pharmacovigilance inspection findings and to identify and discuss the areas where there are differences in the requirements. The challenges in the conduct of pharmacovigilance in a global environment will also be identified and discussed from the industry perspective with the aim to collect proposals for the future.
Learning Objective : Discuss the coordination of pharmacovigilance inspections in the EU and US; Discuss the challenges of conducting pharmacovigilance in a global environment; Identify common areas and practices that give rise to the majority of inspection findings; Use the knowledge and information acquired to improve practices, apply preventive actions and achieve global compliance with pharmacovigilance obligations.
Speaker(s)
Pharmacovigilance Audits: Is the US Behind the Curve?
Michael Oluseun Baptist
Medpace, Inc., United States
Quality Assurance Manager
FDA Perspective
Douglas B. Pham, JD, PharmD
FDA, United States
Regulatory Counsel, Office of Scientific Investigations, OC, CDER
EMA Perspective
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
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