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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
Anthony Lawler, MD, MBA
Therapeutic Goods Administration, Australia
Deputy Secretary, Health Products Regulation Group
Panelist
Antonio Barra Torres, MD
ANVISA, Brazil
President Director
Panelist
Lorraine Nolan, PhD
Health Products Regulatory Authority , Ireland
Chief Executive
Panelist
Daisuke Koga, MSc, RPh
Ministry of Health, Labour and Welfare (MHLW), Japan
Director, Office of International Regulatory Affairs
Panelist
Robert M. Califf, MD
FDA, United States
Commissioner
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