Welcome to CAREB - Bienvenue a l'ACCER

CAREB Network Forum:
New Developments in the Management of Adverse Events
Fairmont Waterfront Hotel
900 Canada Place Way, Vancouver, B.C.
Thursday, April 30th, 2009 4:00 p.m. – 6:30 p.m.
4:00 – 4:10 Welcome and Introduction
Dr. Ray Saginur, Chair, Human Research Ethics Board, Ottawa Hospital
• The current system and why it isn’t working
• 4:00 – 4:20 New Developments in the EU and the U.S.
Marianne Vanderwel, IRB Services
• FDA Guidance
• EU Directive
Dr. Vernon Stringer, MD, MSC, Acting Director, Therapeutic Products Directorate, Health Canada
• Draft (Step 2) ICH E2F

4:20 – 4:50 Summary Reports in Canada – What some Canadian Companies are Doing
Connie Dupuis, Country Study Manager, Roche Canada
Ruth Bell, Manager, Safety Drug Regulatory Affairs, Pfizer Canada Inc.

4:50 – 5:10 Research Ethics Board Response / Perspective
Dr. Ray Saginur, Ottawa Hospital
Dr. Joseph Connors, BC Cancer Research Ethics Board
5:10 – 5:30 Health Canada’s Perspective
Dr. Vernon Stringer, MD., MSC, Acting Director, Office of Clinical Trials Therapeutic Directorate
5:30 – 5:50 The Potential Role for Data Safety Monitoring Boards or similar committees ?
Dr. Robert Peterson, Director, BC Child Health Network, former Director, TPD.
5:50 – 6:20 Moving Forward: Facilitated Minuted Discussion generating a report and
Recommended move-forward action.
Laurel Evans, Associate Director, Research Ethics, UBC
Janet Manzo, Executive Director, Ontario Cancer Research Ethics Board
6:20 – 6:30 Wrap Up and Thank You
Dr. Ray Saginur, Ottawa Hospital