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Session 3 Track B: Regulatory Modernization Health Biosciences
Session Chair(s)
Fiona M Frappier, PhD
Senior Policy Analyst
Health Canada, Canada
Last year consultations were held to support the Government of Canada’s agenda of ensuring that regulations remain flexible and agile to support economic competitiveness. Key trends in the health and biosciences environment include the increasing convergence of drugs, devices, diagnostics, biologics, and a need to navigate the food and drug regulations with varying product risk profiles. To address these issues, Health Canada is developing a clinical trials framework across its business lines (human drug clinical trials, medical device investigational testing, non-prescription drugs and natural health product clinical trials, experimental studies of veterinary drugs, and food clinical trials). Health Canada has been working collaboratively with partners across the health, and innovation ecosystem to develop a Regulatory Sandbox for these most innovative health products. This session will present the perspective of key stakeholders on what should be the path forward to support innovation and facilitate market entry of safe, effective, and high quality health products for all Canadians.
Learning Objective : At the conclusion of this session, participants should be able to:- Recongnize key feedback on Regulatory Review from stakeholder consultations
Speaker(s)
Speaker
Elizabeth Toller, MA
Health Canada, Canada
Associate Director General, Policy, Planning and International Affairs Directora
Speaker
Carole Legare, MD
Health Canada, Canada
Director, Office of Clinical Trials, TPD
Speaker
Kim Dayman-Rutkus, LLM
Health Canada, Canada
Senior Regulatory Advisor
Speaker
Kenneth Joly, MS
Health Canada, Canada
Senior Policy Analyst, Office of Advanced Therapeutic Products
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