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ICMRA – The Future of Medicines and Challenges for International Regulators
Session Chair(s)
Ian Hudson
Senior Advisor, Integrated Development, Bill and Melinda Gates Foundation, United States
The International Coalition of Medicines Regulatory Authorities (ICMRA) will explore some of the key challenges and opportunities for medicines regulation presented by emerging technologies and novel pathways across the international landscape. The session will be delivered by members of ICMRA’s Executive Committee who represent the European medicines regulatory system, including a number of leading regulators. Presentations will include examples drawn from members’ current experience of emerging technologies and an overview of ICMRA’s strategic priorities moving forward, including artificial intelligence, software, ATMPs and 3D printing. The session will conclude with a panel discussion of questions raised by the audience.
Speaker(s)
A Brief Introduction to ICMRA
Ian Hudson
Senior Advisor, Integrated Development, Bill and Melinda Gates Foundation, United States
Overview of ICMRA’s Strategic Priorities
Supriya Sharma, MD, MPH, FRCPC
Chief Medical Advisor, Health Canada, Canada
Example of Emerging Technologies - ATMPs
Tatsuya Kondo, MD, PhD
President, SH Medical Excellence JAPAN, Japan
Example of Emerging Technologies – Digital, Artificial Intelligence/Software
Rita Purcell, LLM
Deputy Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
Example of Emerging Technologies – 3D Printing
John Skerritt, PhD
Enterprise Professor, Health Research Impact, University of Melbourne, Australia
ICMRA Moving Forward – The ‘Innovation’ Priority Project
Rita Purcell, LLM
Deputy Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
Panel Discussion
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
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