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New Approaches to International Collaboration Between Regulators (Part 1 of 2)
Session Chair(s)
Emer Cooke, MBA, MSc
Executive Director, Chair, ICMRA
The 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)
Panelist
Sandra Kweder, MD
Greenleaf Health/Elilquent, United States
Principal, Drug and Biological Products
Panelist
Guido Rasi, MD
Tor Vergata University of Rome, Italy
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology
Panelist
Tatsuya Kondo, MD, PhD
SH Medical Excellence JAPAN, Japan
President
Panelist
Supriya Sharma, MD, MPH, FRCPC
Health Canada, Canada
Chief Medical Advisor
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