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IMPLICATIONS OF THE NEW PHARMACOVIGILANCE LEGISLATION
Session Chair(s)
Deirdre McCarthy, MSc
Senior Director, Pharmacovigilance and Safety Operations
Allovir, United States
Learning Objective : Attendees will learn practical tips on compiling PBRER-style PSURs and other aggregate reports, hear about regulatory authority feedback on submitted reports, and understand the quality management expectations for aggregate reports and risk management plans.
Speaker(s)
Overview of New EU Legislative Framework – Rationale for PSUR and RMP revamp
Deirdre McCarthy, MSc
Allovir, United States
Senior Director, Pharmacovigilance and Safety Operations
Interconnection between the different safety documents in the new pharmacovigilance regulatory environment
Veronique Basch, PharmD
UBC, Switzerland
Executive Director, Global Pharmacovigilance
The New Aggregate Safety Reports: How are we doing?
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
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