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Session 2, Track C: Update on Health Canada’s PV Guidances and Ongoing Initiatives
Session Chair(s)
Randy Levitt, PhD
Director, Pharmacovigilance and Medical Affairs
Paladin Pharma Inc., Canada
Nadiya Jirova, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
Health Canada, Canada
Information session on ongoing Health Canada post market initiatives for risk management plans. This session will include a presentation on global perspectives on risk management and increased need for real-world evidence to support decision-making post marketing. There will also be an update on Agile Regulations for Risk Management Plans (RMP) and best practices when preparing/updating an RMP for a Canadian product followed by a broad panel discussion.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the requirements for RMP submission under upcoming Agile Regulations
- Best practices for RMP submission to Health Canada
- Gain a global perspective on risk management
Speaker(s)
Risk Management Planning: Current and Future State
Rania Mouchantaf, PhD
Health Canada, Canada
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
Risk Management Plans – Modernization of Review Processes and Best Practices
Marie-Therese Bawolak, PhD
Health Canada, Canada
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products