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Hilton Lac-Leamy

Nov 05, 2019 7:30 AM - Nov 06, 2019 3:15 PM

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

DIA Annual Canadian Meeting

Session 3 Track B: Regulatory Modernization Health Biosciences

Session Chair(s)

Fiona M Frappier, PhD

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)

Elizabeth  Toller, MA

Speaker

Elizabeth Toller, MA

Health Canada, Canada

Associate Director General, Policy, Planning and International Affairs Directora

Carole  Legare, MD

Speaker

Carole Legare, MD

Health Canada, Canada

Director, Office of Clinical Trials, TPD

Kim  Dayman-Rutkus, LLM

Speaker

Kim Dayman-Rutkus, LLM

Health Canada, Canada

Senior Regulatory Advisor

Kenneth  Joly, MS

Speaker

Kenneth Joly, MS

Health Canada, Canada

Senior Policy Analyst, Office of Advanced Therapeutic Products

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