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ICMRA Post-Pandemic: Regulators Looking into the Future
Session Chair(s)
Emer Cooke, MBA, MSC
Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
ICMRA regulators will share their views on the opportunities and challenges brought by some of the main innovative concepts and technologies they are facing, including artificial intelligence, evolving clinical trials, and real-world evidence in the authorization of advanced therapy medical products (ATMPs).
Learning Objective : Identify how regulators are working on maximizing the opportunities offered by artificial intelligence while minimizing the risks; Discuss new concepts for enhanced clinical trials (e.g.: platform CTs, decentralized CTs); Describe opportunities and challenges brought by the use of real-world evidence data for authorization of advanced therapy medical products.
Speaker(s)
Panelist
Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
Panelist
President Director, ANVISA, Brazil
Panelist
Chief Executive, Health Products Regulatory Authority , Ireland
Panelist
Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist
Instructor, Medicine, Duke University School of Medicine, United States
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