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Hilton Lac-Leamy

14 nov 2024 7:30 a.m. - 15 nov 2024 4:10 p.m.

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

Canada Annual Meeting

The Canada Annual Meeting offers three tracks, Regulatory, Clinical, Safety and Pharmacovigilance!

Session 2, Track C: Update on Health Canada’s PV Guidances and Ongoing Initiatives

Session Chair(s)

Randy  Levitt, PhD

Randy Levitt, PhD

Director, Pharmacovigilance and Medical Affairs

Paladin Pharma Inc., Canada

Nadiya  Jirova, MSc

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

Risk Management Planning: Current and Future State

Rania Mouchantaf, PhD

Health Canada, Canada

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD

Marie-Therese  Bawolak, PhD

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

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