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SESSION 3: PERIODIC REPORTS AND RISK MANAGEMENT PLANS
Session Chair(s)
Shelley Gandhi, MSc
Strategic Advisor, Pharmacovigilance and Drug Safety
NDA Group, United Kingdom
This session will describe how the QPPV can assure and demonstrate the quality, accuracy, completeness and timeliness of PSURs/PBRERs, risk management plans and design of risk minimisation measures.
Speaker(s)
PERIODIC REPORTS AND RISK MANAGEMENT PLANS
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
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