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Session 2, Track C: Update on Health Canada’s PV Guidances and Ongoing Initiatives
Session Chair(s)
Randy Levitt, PhD
PV & Medical Affairs Professional , Unemployed, 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)
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Risk Management Planning: Current and Future State
Marie-Therese Bawolak, PhD
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products, Health Canada, Canada
Risk Management Plans – Modernization of Review Processes and Best Practices