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Session 1108: QUALITY IN PHARMACOVIGILANCE
Session Chair(s)
Xue TANG
Drug Safety Unit Regional Head (DRH),
APAC Pfizer, China
Pharmacovigilance (PV) is an integrated system which combined multi-science to collect, identify, evaluate, monitor and analyze an adverse event. To ensure it is operating effectively and with high quality, a set of examination measures is necessary in order to identify the issue and risk as well as to resolve the issue in the end. Internal audit within the enterprise and the inspection by health authority are activities to improve the quality management of the PV system. Europe and the US has taken the steps with experience, EMA has issued Good Pharmacovigilance Practice in its new legislation in July 2012 and defined the legal responsibility of both health authority and the enterprise to implement the audit/inspection of PV.
Speaker(s)
Introduction on "Guidance on the On-Site Inspection of Adverse Drug Reaction Reporting and Monitoring by Manufacturing Enterprises"
Duo Dong
China Food and Drug Administration (CFDA), China
Deputy Division Director, National Center for ADA Monitoring
Pharmacovigilance Inspections - Perspectives on Preparation and Management
Helen Li, MD, MBA
Pfizer Medical, China
Director, Emerging Market QA Asia Lead
Yuan Yao
Novartis China, China
Head of PVO China, AD
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