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San Diego Convention Center

Jun 16, 2024 7:00 AM - Jun 20, 2024 3:00 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2024 Global Annual Meeting

Join us at the premier life sciences conference, celebrating our 60th anniversary! Discover 180+ sessions on Cell and Gene Therapy, Decentralized Clinical Trials, AI, ICH, and more. Get ready to tackle challenges, improve skills, network, and drive change for healthcare at DIA2024.

International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

Session Chair(s)

Antonio  Barra Torres, MD

Antonio Barra Torres, MD

President Director, ANVISA, Brazil

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 Objective : 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.

Speaker(s)

Emer  Cooke, MBA, MSC

Promoting International Regulatory Convergence Through Regulatory Science

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Yasuhiro  Fujiwara, MD, PHD

Path for Future Collaboration Utilizing Regulatory Science

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Robert M. Califf, MD

Regulatory Science Impact Stories

Instructor, Medicine, Duke University School of Medicine, United States

Anthony  Lawler, MD, MBA

ICMRA Summit 2023: Regulators Working Together Towards the Future

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

Alison  Cave

Panelist

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Pamela  Aung-Thin

Panelist

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

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