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Pharmacovigilance Inspector Fireside Chat
Session Chair(s)
Sophie Radicke, MSc
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
A rare opportunity to hear inspectors from three global regulators compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts.
Learning Objective : Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.
Speaker(s)
Health Canada Perspective
Stephane Berard
Health Canada, Canada
Interim Supervisor-Health Product Compliance East Unit
FDA Perspective
Representative Invited
FDA, United States
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