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PHARMACOVIGILANCE – INNOVATION AND INTERFACES
Session Chair(s)
Joan Gilvarry, DrMed, FRCP
Director of Human Products Monitoring
Irish Medicines Board, Ireland
Learning Objective : 1) Understand implications of new arrangements for assessing efficacy and what are current regulatory expectations 2) Discover what solutions are available for handling cases, assessing causal relationship and regulatory classification and applying everyday solutions. 3)Visualise the interface between assessment of effectiveness and other pharmacovigilance processes
Speaker(s)
Fitting the jigsaw puzzle together – leveraging the integrated approach for improved safety and quality outcomes
Nicole Baker, PhD
Quintiles, Ireland
Associate Director, Customer Delivery Europe
How will assessment of effectiveness be integrated into the pharmacovigilance system?
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
Pharmacovigilance in a biotech start-up company: Experiences from marketing the first ATMP in the EU
Ludo Haazen, MD
CERTOR, Belgium
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