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Session 2, Track A: Evolving Regulatory Landscapes: Key Updates in Health Canada's Regulations, Policies, Guidance and Compliance Framework
Session Chair(s)
Hocine Abid, MD, MBA
National Manager, Regulatory Operations and Enforcement Branch, Health Canada, Canada
Yatika Kohli, MBA
Chief Compliance and Strategy Officer, NoNO Inc, Canada
This session provides an overview of Health Canada’s latest updates on regulatory and policy initiatives, including agile licensing regulatory amendments, risk management plan requirements, and compliance and enforcement initiatives . Attendees will gain insights into upcoming changes in policies, emerging guidance documents and evolving standards impacting the regulated environment of health products in Canada. Health Canada speakers will provide updates and answer questions related to key HC regulatory modernization and policy initiatives related to: Advanced Therapeutic Products Framework and modernization of requirements for biologic drugs. Advancements made under the Pediatric Drug Action Plan will also be shared; Guidance related to implementation of Agile regulations for Terms and Conditions for drugs, Guidance document: Information and Submission Requirements for Biosimilar Biologic Drugs and; Management of Workload and mitigation measures to address the backlog of drug submissions.
- Updates on Regulatory Modernization and the Pediatric Drug Action Plan
Nicole van der Lee, Senior Policy Analyst, Health Canada - Terms and Conditions (Drugs)
Kristen Zorn, Health Canada - Proposed Changes to Health Canada Guidance for Biosimilar Biologic Drugs Submissions
Denis Arsenault, Biologic, Health Canada - Health Canada’s Management of Workload and Backlog
Elana Cherry, Health Canada
Learning Objective : - Identify strategies for involvement in the public consultation process related to the government regulatory initiatives in relation to Agile Regulations, Policies and Guidance documents
- Explain key changes proposed to the Guidance document: Information and submission requirements for Biosimilar Biologic Drugs (Biosimilars Guidance)
- Recognize the mitigation measures implemented by Health Canada for management of workload and backlog
Speaker(s)
Nicole van der Lee
Associate Director, Health Canada, Canada
Updates on Pediatric Drug Action Plan and Regulatory Modernatization: Advanced Therapeutic Products
Kristen Zorn
Manager, Policy Development, Pharmaceutical Drugs Directorate, Health Canada, Canada
Terms and Conditions (Drugs)
Denis Arsenault, MBA
Manager, Policy Development, Biologic and Radiopharmaceutical Drugs Directorate,, Health Canada, Canada
Proposed Revisions of Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs
Elana Cherry, PHD
Director, Center for Blood, Blood Products, and Biotherapeutics, Health Canada, Canada
Health Canada’s Management of Workload and Backlog
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