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Session 1 Plenary: Understanding Health Canada’s Precision Regulating Initiatives
Session Chair(s)
Katalin Bertenyi, MSc
Manager, Centre for Blood, Blood Products and Biotherapeutics
Health Canada, Canada
My Dang, MBA
Director/Consultant, Regulatory Affairs
Cencora, Canada
In this plenary session, Health Canada representatives will provide an overview of recent amendments to the Food and Drugs Act, which will enable precise regulatory solutions to a variety of potential situations.
Where a situation requiring action has been identified and where the requirements of the legislation have been met, the new authorities would enable the Minister of Health to make a Ministerial Order to:
- Put in place targeted exemptions from specific regulatory requirements, while adding conditions as appropriate to ensure that health and safety standards are met
- Rely on information or decisions from select regulatory authorities to satisfy specific regulatory requirements
- Put in place supplementary rules for certain therapeutic products to protect against potential health risks or adverse effects
These are adaptable tools which could be used in a variety of situations; for example, to maintain product availability in the event of a shortage, remove barriers that create areas of unmet need or address potential health risks or adverse effects.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain the changes to the Food and Drugs Act
- Discuss the first use cases under Precision Regulating
- Describe Precision Regulating and its regulatory impact to industry
Speaker(s)
Speaker
Patricia Dechman
Health Canada, Canada
Acting Director, Strategic Horizontal Policy Division
Speaker
Alysha Croker, PhD
Health Canada, Canada
Director, Centre for Policy, Pediatrics and International Collaboration, BRDD