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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. This session will include a presentation on the most recent guidance documents open for consultations and ongoing stakeholder engagement. 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 discussion on current and future state in risk management in Canada and worldwide.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify Health Canada Guidance Documents open for consultation
- 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)
Speaker
Representative Invited
Health Canada, Canada
Speaker
Representative Invited
Health Canada, Canada
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