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Global Pediatric Development: We Are Making Progress

Track:
Regulatory Affairs and Submissions

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
111

Room Number:
30AB

Level:
Intermediate

Type:
Session

Title:
Global Pediatric Development: We Are Making Progress

Chair(s):
Chin Koerner, MS
Executive Director, Regulatory Policy
Novartis Pharmaceuticals Corporation, United States

Description:
Representatives from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceutical and Medical Device Agency (PMDA) will provide the latest regional policy developments, share examples of similar policies and agreements and share examples where the agencies differ.

Learning Objective(s):
Discuss the latest policy developments in the three regions in pediatric research.

Presentation(s) & Speaker(s):
Into the Future: Go Global Pediatric Development Forward for Children Worldwide — Beyond Current Regulations
Junko Sato, DrSc, PhD
Director, Division of Regulatory Cooperation, Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

FDA Perspective
Dianne Murphy, MD
Director, Office of Pediatric Therapeutics, OSMP, OMPT, OC
FDA, United States

EMA Perspective
Jordi Llinares Garcia, DrMed, MSc
Head of Product Development Scientific Support Department
European Medicines Agency, European Union, United Kingdom