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Session 7: Track B: Pharmacovigilance: To Detect or Not to Detect
Session Chair(s)
Marc Poitras, PHD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
Identifying new potential risks and ongoing monitoring of identified risks constitute the essence of all pharmacovigilance activities throughout the product lifecycle. In this session, experts in the field will discuss different aspects of pharmacovigilance/signal detection including different signal management tools for different product lines.
Learning Objective : At the conclusion of this session, the participant should be able to:- Discuss the new regulatory changes in EU and US from a safety signal perspective
- Identify the challenges and complexities of Vaccine vigilance
- Describe confusion/medication errors and their impact on patients’ safety
Speaker(s)
Mugdha Chopra, DDS
Co-Founder and Director, AWINSA Life Sciences, United States
EU and US Approaches Towards Signal Detection in Vaccines
Zsuzsanna Gesztesi, MD
Director, Patient Safety and Medical Information, AstraZeneca Canada Inc., Canada
Pharmacovigilance Analysis of Product Confusion Errors and Issues in Canada - A Pharmacovigilance Assessment
Sanjeev Miglani, MD
Founder and Director, AWINSA Life Sciences, United States
Insight into Different Signal Management Tools: New Regulatory Perspectives