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Session 2, Tracks A, B, C: Advancing Agile Regulations for Drugs: Updates from Health Canada
Session Chair(s)
Mandy Collier
Director, Health Products and Food Branch
Health Canada, Canada
Melanie Cote, MS
Senior Manager, Regulatory Affairs
Otsuka, Canada
Between December 2022 and April 2023, Health Canada consulted on new regulatory proposals and guidance documents of the Agile Licensing for Drugs initiative. These are part of the department’s Regulatory Innovation Agenda aimed at reducing regulatory irritants and modernizing its regulations based on agile tools tested through the COVID-19 response. In this session, speakers from Health Canada will situate the Agile Licensing for Drugs initiative within the modernization agenda and provide updates on the consultation feedback and planned next steps, in particular for the use of Terms and Conditions, Risk Management Plans, and Rolling Reviews.
Learning Objective : - Contextualize the Agile Licensing for Drugs initiative within Health Canada’s (HC’s) Regulatory Innovation Agenda
- Identify key themes and feedback heard during HC‘s consultation, including the use of terms and conditions, risk management plans, and rolling reviews
- Gain insights on plans for next steps
Speaker(s)
Speaker
Saskia De Moree, JD, MA
Health Canada, Canada
Manager, Office of Legislative and Regulatory Modernization
Agile Licensing for Drugs: Terms and Conditions
Nadia Giancaspro
Health Canada, Canada
Senior Policy Analyst
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
Robyn Blom
Health Canada, Canada
Health Products and Food Branch, Pharmaceutical Drugs Directorate
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