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Session 2: Understanding Health Canada’s Regulatory Modernization Plans: Agile Licensing for Drugs
Session Chair(s)
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
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)
Regulatory Innovation at Health Canada: Advancing agile regulations for drugs
Saskia De Moree, JD, MA
Health Canada, Canada
Manager, Office of Legislative and Regulatory Modernization
Agile Licensing for Drugs: Terms and Conditions
Kristen Zorn
Health Canada, Canada
Associate Director / Manager, Policy Development
Agile Licensing for Drugs: Risk Management Plans
Bruce Wozny, MA
Health Canada, Canada
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products
Agile Licensing for Drugs: Rolling Reviews
Denis Arsenault, MBA
Health Canada, Canada
Manager, Policy Development, Health Products and Food Branch, Biologic and
Panelist: Agile Licensing for Drugs: Terms and Conditions
Nadia Giancaspro
Health Canada, Canada
Senior Policy Analyst