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New Approaches to International Collaboration Between Regulators (Part 1 of 2)
Session Chair(s)
Emer Cooke, MBA
Executive Director, European Medicines Agency, Netherlands
Starting with the original ICH partners, this forum will explore how the model of regulatory collaboration is evolving from traditional harmonization and information sharing models to strategic coalitions and work-sharing initiatives. It will examine emerging efforts to avoid duplication and increase mutual reliance between regulators and their impact on industry.
Part 2 will take place on Monday at 11:00 AM (Session #144).
Learning Objective : Discuss the current challenges facing international regulators including how this impacts the pharmaceutical industry and patients; Describe emerging international regulatory initiatives.
Speaker(s)
Sandra Kweder, MD
Principal, Drug and Biological Products , Eliquent Life Sciences, United States
Panelist
Guido Rasi, MD
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology, Tor Vergata University of Rome, Italy
Panelist
Tatsuya Kondo, MD, PHD
President, SH Medical Excellence JAPAN, Japan
Panelist
Supriya Sharma, MD, MPH, FRCPC
Chief Medical Advisor, Health Canada, Canada
Panelist
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