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Session 4 Track C - Pharmacovigilance and Risk Management: Safety Surveillance of Scientific Literature for Medical Devices, Drugs, and Combination Products
Session Chair(s)
Ljubica Ivanisevic, PhD
Scientific Evaluator
Health Canada, Canada
The session will discuss approaches and methodologies used to screen scientific literature in order to enhance the ability to identify important safety signals. Representatives from Health Canada and Industry will discuss specific methods used/challenges/pitfalls with regards to safety surveillance of medical devices, drugs and combination products.
Speaker(s)
Safety Surveillance of Scientific Literature Related to Combination Products
Robert F. Reder, DrMed, MD
Abbvie, United States
Senior Medical Director
Health Canada Approach to Safety Signal Detection through the Scientific Literature for Medical Devices
Rana FilFil, PhD
Health Canada, Canada
Scientific Evaluator
Health Canada Approach to Safety Signal Detection through the Scientific Literature for Pharmaceutical Products
David Duguay, PhD
Health Canada , Canada
, Pharmacovigilance Scientific Manager, Marketed Pharmaceuticals Bureau at MHPD
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