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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, Global Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization Inc., 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)
Saskia De Moree, JD, MA
Manager, Office of Legislative and Regulatory Modernization, Health Canada, Canada
Speaker
Nadia Giancaspro
Senior Policy Analyst, Health Canada, Canada
Agile Licensing for Drugs: Terms and Conditions
Bruce Wozny, MA
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products, Health Canada, Canada
Agile Licensing for Drugs: Risk Management Plans
Denis Arsenault, MBA
Manager, Policy Development, Biologic and Radiopharmaceutical Drugs Directorate,, Health Canada, Canada
Agile Licensing for Drugs: Rolling Reviews
Robyn Blom
Health Products and Food Branch, Pharmaceutical Drugs Directorate, Health Canada, Canada
Panelist