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ICMRA – The Future of Medicines and Challenges for International Regulators

Track:
Hot Topic/Stand Alone

Day & Time:
April 18, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:
S1002

Room Number:
Kairo 1-2

Type:
Session

Title:
ICMRA – The Future of Medicines and Challenges for International Regulators

Chair(s):
Ian Hudson
Chief Executive
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Description:
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.

Presentation(s) & Speaker(s):
A Brief Introduction to ICMRA
Ian Hudson
Chief Executive
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Overview of ICMRA’s Strategic Priorities
Supriya Sharma, MD, MPH, FRCPC
Associate Assistant Deputy Minister of Health Products and Food Branch
Health Canada, Canada

Example of Emerging Technologies - ATMPs
Tatsuya Kondo, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), 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
ICMRA Project Lead; Deputy Secretary for Health Products Regulation
Department of Health, 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, MD
Head of International Affairs, Head of Portfolio Board
European Medicines Agency (EMA), United Kingdom