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Session Chair(s)
Agnes Klein, MD
Senior Medical Advisor
Health Canada, Canada
Learning Objective : Identify various regulatory approaches in different international jurisdictions; Discuss a broad brush overview of diverse ways regulations can be approached; Explain the participation of Canada in international endeavors that will facilitate and improve the development of therapeutics.
Speaker(s)
International Collaborations in Clinical Trials
Agnes Klein, MD
Health Canada, Canada
Senior Medical Advisor
Orphan Drugs Regulations and Framework
Marcin Boruk, MBA, MSC
Health Canada, Canada
acting Director, Business Facilitation and Modernization Directorate, Health Can
Update on the Adoption and Implementation of ICH E2C (R2): Periodic Benefit-risk Evaluation Reporting in Canada
Vicky Ann Hogan, PHD, MSC
Health Canada, Canada
Manager, Blood Tissues and Organs Scientific Section
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