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Paediatric Policy Initiatives: Globalisation of Paediatric Drug Development Best Practice or Imperialism of Practice?

Track:
Drug Development and Regulatory Approval - Reference Points around the Globe or Globalisation?

Day & Time:
April 18, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:
S0802

Room Number:
Shanghai 3

Level:
Intermediate

Type:
Session

Title:
Paediatric Policy Initiatives: Globalisation of Paediatric Drug Development Best Practice or Imperialism of Practice?

Chair(s):
Christina Bucci-Rechtweg, MD
Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs
Novartis Pharmaceuticals Corporation, United States

Description:
Paediatric legislation implementing a system of obligations and rewards has led to a significant increase in paediatric studies. Whilst studies conducted are multinational, regional regulatory objectives may not serve global research needs. This session will utilise a series of cases which highlight the global nature of paediatric drug development.

Presentation(s) & Speaker(s):
Panel Discussion
Julia Bielicki
Attending Physician Pediatrics & Pediatric Infectious Diseases,
University Children's Hospital Basel, Switzerland

Panel Discussion
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy
MSD (Europe) Inc., Belgium

Panel Discussion
Frank Van den Ouweland, DrMed, PhD
Medicines Authorisations
Swissmedic, Switzerland

Panel Discussion
Cesare Spadoni
Founder and Chairman of the Board
aPODD Foundation, United Kingdom