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Safety Audits and Inspections

Learn about safety audits and inspections with a focus on FDA, EMA, MHRA, and Health Canada inspections.

Authors

Mary  Mease, MPH, RPh

Mary Mease, MPH, RPh

PV and Risk Management Strategy and Operations, Consultant, United States

Ms. Mease leads safety and REMS at Quintiles. She served as an expert for 11 yrs at the FDA/CDER on drug benefit risk communication, risk management, and pharmacovigilance and led the establishment of CDER’s Drug Safety Oversight Board. She holds a BS in Pharmacy and a Masters in Public Health.

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