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Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Session Chair(s)
Sophie Radicke, MSc
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.
Learning Objective : Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.
Speaker(s)
US FDA Perspective
Representative Invited
FDA, United States
Health Canada Perspective
Myriam Salem, MSc
Health Canada, Canada
Good Pharmacovigilance Practices National Coordinator
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