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International Regulatory Convergence
Session Chair(s)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Discuss how regulators approach relative effectiveness in various jurisdictions. The opportunity arises at a time when the EU is discussing joint evaluations and legal framework. Canada is also working on interactions with the bodies responsible for this evaluation. Japan has initiated a pilot on relative effectiveness comparison.
We intend to show how international regulatory authorities could cooperate and share experience to ensure global coordination of data, studies, and evaluation in the context of global development.
Learning Objective : Discuss how the main regulatory Agencies collaborate and work with those involved in relative effectiveness and added therapeutic value of medicines; Identify the common criteria used and determine when independence should be maintained; Examine specific issues with Advanced Therapies/regenerative medicines and added value; Describe the importance of collaboration at the international level
Speaker(s)
Guido Rasi, MD
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology, Tor Vergata University of Rome, Italy
Panelist
Pierre Sabourin, MBA
Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Panelist
Brian O'Rourke, PharmD
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health, Canada
Panelist
Giovanni Tafuri, PhD, MS
Senior Scientific Officer, EUnetHTA, Netherlands
Panelist
Katsuaki Ura
Deputy Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Panelist
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