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Plenary Session 1: International Regulatory Cooperation: Trends and Impacts

Track:
Plenary Session

Day & Time:
October 29, 9:00AM - 10:30AM

Type:
Session

Title:
Plenary Session 1: International Regulatory Cooperation: Trends and Impacts

Chair(s):
Matthew Ryan
Senior Advisor, Director General's Office, Therapeutic Products's Directorate
Health Canada, Canada

Chanez-Narimene Kebache
Manager, Pharmacovigilance
Mallinckrodt Pharmaceutical, Canada

Description:
Hear from key leaders from international regulators on current trends, activities and the future of collaboration amongst key agencies. International cooperation is having a shifting impact on public policy and drug regulation, and will continue to shape and impact agency activities. Learn about these key initiatives, where agencies are focusing their activities and how interagency collaboration is evolving now and into the future. Attendees will hear about the impacts of these new realities of international regulatory cooperation and what this means for key stakeholders in the development and regulation of health products.

Presentation(s) & Speaker(s):
Health Canada Perspective
Louise Déry
Director, Policy, Planning and International Affairs Directorate
Health Canada, Canada

EMA Perspective
Sabine Haubenreisser, PhD
EMA Liaison Official to the US FDA
European Medicines Agency, European Union, United States

Embedment of Health Canada National Visiting Expert (NVE) in Pharmacovigilance at European Medicines Agency - Pilot Project (Via Video Communications)
Christopher Turner, MD,FRCPC
Director General
Health Canada / EMA, Canada

© 2014