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Session 4 Track A: Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices
Session Chair(s)
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
Innovative technologies are dramatically changing the health landscape. This complex, modern health environment requires new regulatory approaches to enable access to novel and innovative health technologies, while continuing to protect patient safety. In this interactive session, Health Canada leadership will discuss key projects in the Department’s Regulatory Innovation Agenda, including modernizing clinical trial regulations, enabling Advanced Therapeutic Products, pursuing agile licensing for drugs and medical devices, and advancing modernization in compliance and enforcement. In addition, the presenters will discuss lessons learned from Health Canada’s agile regulatory response to COVID-19, the impact of the pandemic on the Regulatory Innovation Agenda, and our path forward.
Learning Objective : At the conclusion of this session, participants should be able to:
- Summarize the key pillars of Health Canada’s Regulatory Innovation Agenda
- Explain how the Regulatory Innovation Agenda will support access to innovative health technologies
- Describe agile regulatory measures introduced in response to COVID-19
Speaker(s)
Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices
Elizabeth Toller, MA
Health Canada, Canada
Associate Director General, Policy, Planning and International Affairs Directora
Regulatory Innovation at Health Canada: Advancing agile regulations for drugs and devices
Carole Legare, MD
Health Canada, Canada
Director, Office of Clinical Trials, TPD
Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices
Celia Lourenco, PhD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
Speaker
David Boudreau
Health Canada, Canada
Director General, Medical Devices Directorate, Health Products and Food Branch
Speaker
Catherine Hudon, MPA
Health Canada, Canada