DIA Annual Canadian Meeting

Transformation with Collaboration

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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)

EU and US Approaches Towards Signal Detection in Vaccines

Mugdha Chopra, DDS

AWINSA Life Sciences, United States

Co-Founder and Director

Pharmacovigilance Analysis of Product Confusion Errors and Issues in Canada - A Pharmacovigilance Assessment

Zsuzsanna Gesztesi, MD

AstraZeneca Canada Inc., Canada

Director, Patient Safety and Medical Information

Insight into Different Signal Management Tools: New Regulatory Perspectives

Sanjeev Miglani, MD