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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?

Session Chair(s)

Max  Wegner, PharmD, RPh

Max Wegner, PharmD, RPh

Head Regulatory Affairs

Bayer AG, Germany

An evolving regulatory framework supports and incentivizes pediatric drug development. This session compares recent experience in the US, EU, China, and Canada and explores options for advancing global approaches.

Learning Objective : Discuss the evolving global regulatory framework for development of pediatric medicines in the US, EU, China, and Canada; Describe common challenges and opportunities faced with global planning and conduct of pediatric programs; Review case studies illustrating a global approach for development of pediatric medicines.

Speaker(s)

Alysha  Croker, PhD

Health Canada Perspectives

Alysha Croker, PhD

Health Canada, Canada

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD

Lynne  Yao, MD

Can Increasing Collaboration Lead to Fewer Unnecessary Clinical Trials? FDA Perspectives

Lynne Yao, MD

FDA, United States

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER

Zhimin  Yang, MD

Considerations on Promoting Pediatric Clinical Trials in China: Perspective from Agency

Zhimin Yang, MD

National Medical Products Administration (NMPA), China

Deputy Director, Center for Drug Evaluation

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