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Wednesday, June 17 • 9:30am - 10:30am
#312 L: Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-585-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Max Wegner, PharmD, RPh

Speaker

Health Canada Update
Alysha Croker, PhD

FDA Update
Lynne Yao, MD

NMPA Update
Zhimin Yang, MD


Speakers
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →
avatar for Alysha Croker

Alysha Croker

Manager, Office of Paediatrics and Patient Involvement, Health Canada
Following her PhD in cell biology studying the molecular mechanisms of breast cancer metastasis and therapy resistance, Alysha Croker joined the Canadian Institutes of Health Research in 2013 as an analyst. Since then, she has taken on a number of leadership roles managing high profile... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →
avatar for Zhimin Yang

Zhimin Yang

Division Director, Center for Drug Evaluation, National Medical Products Administration (NMPA)

Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   12: Value-Access, Session