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Session 10: Regional Updates
Session Chair(s)
E. Stewart Geary, MD
MD, Global Safety Officer, Eisai Co., Ltd., Japan
This session focuses on countries or regions where pharmacovigilance regulations are in transition or where recent updates can present compliance issues for clinical trial Sponsors or Marketing Authorization Holders. The Eurasian Economic Union (EAEU), which includes Russia and a number of states in northern Eurasia, now has a Good Pharmacovigilance Practice (GVP) guideline and requirement for a QPPV, which will be described and explained. In Japan the “Three Officer System” is undergoing revisions in the face of a number of compliance issues that have surfaced in that country and the countries Good Postmarketing Survey Practice (GPSP) is also being modified. An update on the implementation of Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act), one of the most significant changes to the Canadian Food and Drug Act in 50 years, and its implications for pharmacovigilance in that country will also be presented.
Speaker(s)
Shinobu Uzu, PHD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The Evolving Situation in Japan: The “Three Officer System” and GPSP
Melissa Hunt, MSC
Director, Health Canada, Canada
Modernization Efforts in Canada: The Regulatory Review of Drugs and Devices and Vanessa’s Law
Simon Johns
Director, Medical Information and Local Affiliate Product Services, IQVIA, United Kingdom
CRO Perspectives on New PV Requirements in the EAEU
Tatyana Prokhorova
Cluster Safety Lead , Pfizer LLC, Russia EAEU/Ukraine QPPV, Russian Federation
What New EAEU PV Obligations Mean for a Global Company with a Focus on Russia