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Session 5: Regulatory Innovation for Health Products: Agile Licensing for Medical Devices
Session Chair(s)
Marcia Sam
Regulatory Affairs Strategy and Policy Manager
Hoffmann-La Roche Canada Limited, Canada
Lorella Garofalo, PhD
Head of Regulatory Sciences
Pfizer Canada, Canada
Building on the progress initiated with the Medical Devices Action Plan as well as learnings from the COVID-19 pandemic, Health Canada will introduce additional agility in the regulatory framework for medical devices. This session will provide an overview of expected changes including, enhanced risk-based regulation, inclusion of tools to support lifecycle oversight and use of foreign decisions. In addition, regulatory considerations for drug-device combinations will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe key elements of Health Canada’s Agile Licensing for Medical Devices
- Define specific attributes of Health Canada’s regulatory innovation plan and identify impact on local and global regulatory strategies
- Recognize the evolving regulatory landscape for medical device technologies and the unique challenges of drug device combinations
Speaker(s)
Regulatory Innovation for Health Products: Agile Licensing for Medical Devices
David Boudreau
Health Canada, Canada
Director General, Medical Devices Directorate, Health Products and Food Branch
Speaker
Mia Spiegelman
Medtech Canada, Canada
Vice President, Regulatory Affairs
Regulatory Innovation for Health Products: Agile Licensing for Medical Devices
Nicole Abou Nakad, MSc
Roche Diagnostics, Canada
Regulatory Affairs Project Manager