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Tuesday, June 18 • 10:00am - 11:00am
#230: International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

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Component Type: Forum
Level: Intermediate

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 Objectives

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.

Chair

Antonio Barra Torres, MD

Speaker

Promoting International Regulatory Convergence Through Regulatory Science
Emer Cooke, MBA, MSc

Path for Future Collaboration Utilizing Regulatory Science
Yasuhiro Fujiwara, MD, PhD

ICMRA Summit 2023: Regulators Working Together Towards the Future
Anthony Lawler, MD, MBA

Panelist
Alison Cave, PhD

Panelist
Pamela Aung-Thin


Speakers
avatar for Pamela Aung-Thin

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
avatar for Emer Cooke

Emer Cooke

Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Anthony Lawler

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
avatar for Antonio Barra Torres

Antonio Barra Torres

President Director, ANVISA, Brazil
Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  14: DIAmond, Forum