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Delta Hotels Ottawa City Centre

Oct 18, 2022 1:00 PM - Oct 19, 2022 9:10 PM

101 Lyon Street North, Ottawa, ON K1R 5T9, Canada

Canada Annual Meeting

Session 5: Regulatory Innovation for Health Products: Agile Licensing for Medical Devices

Session Chair(s)

Marcia  Sam

Marcia Sam

Regulatory Affairs Strategy and Policy Manager

Hoffmann-La Roche Canada Limited, Canada

Lorella  Garofalo, PhD

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)

David  Boudreau

Regulatory Innovation for Health Products: Agile Licensing for Medical Devices: David Boudreau

Director General, Medical Devices Directorate, Health Products and Food Branch

Health Canada, Canada

Mia  Spiegelman

Speaker: Mia Spiegelman

Vice President, Regulatory Affairs

Medtech Canada, Canada

Nicole  Abou Nakad, MSc

Regulatory Innovation for Health Products: Agile Licensing for Medical Devices: Nicole Abou Nakad, MSc

Regulatory Affairs Project Manager

Roche Diagnostics, Canada

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