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10 Years On: Has the Paediatric Regulation Achieved its Aims? A Panel Discussion
Session Chair(s)
Angelika Joos, MPHARM
Executive Director, Science & Regulatory Policy
MSD, Belgium
The Paediatric Regulation is up for a second review in 2017. The EU Commission is currently analysing policy options in this regard and a report analysing the state of play is expected in June. This round table discussion will reflect on the experience, current successes and proposals for optimisation in line with the laws’ objectives after 10 years.
Learning Objective : Explain the current status of paediatric rewards, understand the issues and anticipate the possible changes
Speaker(s)
Legal Perspective
Genevieve Michaux, LLM
King & Spalding International LLP, Belgium
Partner, Life Sciences
Founder’s Perspective
Daniel Brasseur, DrMed
Federal Agency for Medicines Health Products (FAMHP), Belgium
PDCO Chairman
Industry Perspective
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Virginie Hivert, PHARMD, PHD
Eurordis-Rare Diseases Europe, France
Therapeutic Development Director