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International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation
Session Chair(s)
Antonio Barra Torres, MD
President Director, ANVISA, Brazil
Innovative approaches have the potential to create new opportunities for patients, but they also bring challenges to regulators, called to evaluate, and supervise products for which traditional regulatory approaches might not be appropriate. Global regulators will discuss how regulatory science is key to develop solutions and how regulators worldwide need to work together to overcome such challenges.
Learning Objective : Explore how to make faster progress with translating regulatory science research outputs into practice, for accelerating and improving medicine development and use; Discuss generalizable success stories and examples with challenges to an efficient translation; Describe and critically review hurdles and success factors.
Speaker(s)
Promoting International Regulatory Convergence Through Regulatory Science
Emer Cooke, MBA
Executive Director, European Medicines Agency, Netherlands
Path for Future Collaboration Utilizing Regulatory Science
Yasuhiro Fujiwara, MD, PhD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Science Impact Stories
Robert M. Califf, MD, FACC
Instructor, Medicine, Duke University School of Medicine, United States
ICMRA Summit 2023: Regulators Working Together Towards the Future
Anthony Lawler, MD, MBA
Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
Panelist
Alison Cave
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Panelist
Pamela Aung-Thin
Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
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