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Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
Session Chair(s)
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)
Health Canada Perspectives
Alysha Croker, PHD
Health Canada, Canada
Director, Strategic and Horizontal Policy
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
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