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Session 1 Track B: Canada’s Approach to COVID-19 Vaccine Development and Approval
Session Chair(s)
Deborah Danoff, MD, FRCPC
Medical Evaluator, Health Canada, Canada
Fiona M Frappier, PhD
Senior Policy Analyst, Health Canada, Canada
The vaccine development, regulatory review and public health response to COVID-19 have been unprecedented. The innovation and regulatory life cycle frames all aspects of the introduction and revision of therapeutics in Canada. The COVID-19 epidemic has required many innovations to meet Canadian and worldwide needs. This has included a nimble approach to vaccine development and regulatory activities. This presentation provides an in depth perspective on these innovations. Discussion will include success, lessons learned and impact on regulations post pandemic. Using case studies we will explore both the MAH and regulatory authority perspectives.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the regulatory changes that permitted expedited approval of COVID-19 vaccines
- Learn about the impact (timing, resources, unexpected difficulties) of the regulatory changes
- Consider how these changes may inform future regulatory approaches
Speaker(s)
Celia Lourenco, PhD
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Health Canada’s Regulatory Response to COVID-19
Aline Silahian
Associate Director Regulatory Affairs, Pfizer , Canada
Pfizer-BioNTech COVID-19 Vaccine Overview
Leslie D Madden, LLM, MBA
Head of Regulatory Affairs, Canada, Moderna, United States
Speaker
Ron Boch, PhD
Vice President, Biotechnology and Industry Affairs, BIOTECanada, Canada
Speaker