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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 2: Understanding Health Canada’s Regulatory Modernization Plans: Agile Licensing for Drugs

Session Chair(s)

Judith  Mergl, MSc

Judith Mergl, MSc

Director, Regulatory Affairs and Operational Services

AbbVie Corporation, Canada

Mandy  Collier

Mandy Collier

Director, Health Products and Food Branch

Health Canada, Canada

In 2019, building on work begun through the “Regulatory Review of Drugs and Devices”, Health Canada began implementing a multi-year Regulatory Innovation Agenda to enhance Canada’s position as a destination of choice for product submissions through a more modern, agile and internationally-aligned regulatory system. In this session, Speakers from Health Canada will provide an overview of the proposed amendments for the first phase of the Agile Licensing for Drugs initiative. The majority of the proposed amendments are based on agile regulatory tools tested through the COVID-19 response and others are aimed at addressing long-standing industry irritants.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand Health Canada’s plan for regulatory modernization for drugs including the use of Terms and Conditions, Risk Management Plans and Rolling Reviews
  • Discuss the impacts and considerations for Industry

Speaker(s)

Saskia  De Moree, JD, MA

Regulatory Innovation at Health Canada: Advancing agile regulations for drugs: Saskia De Moree, JD, MA

Manager, Office of Legislative and Regulatory Modernization

Health Canada, Canada

Kristen  Zorn

Agile Licensing for Drugs: Terms and Conditions: Kristen Zorn

Associate Director / Manager, Policy Development

Health Canada, Canada

Bruce  Wozny, MA

Agile Licensing for Drugs: Risk Management Plans: Bruce Wozny, MA

Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products

Health Canada, Canada

Denis  Arsenault, MBA

Agile Licensing for Drugs: Rolling Reviews: Denis Arsenault, MBA

Manager, Policy Development, Health Products and Food Branch, Biologic and

Health Canada, Canada

Nadia  Giancaspro

Panelist: Agile Licensing for Drugs: Terms and Conditions: Nadia Giancaspro

Senior Policy Analyst

Health Canada, Canada

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