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Session 5 PAEDIATRIC RELATED INITIATIVES: UPDATE ON PROGRESS
Session Chair(s)
Roberto De Lisa, MD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
This session will give an overview of currently ongoing initiatives that foster understanding and development of new medicines for children and discuss how all these initiatives support the goals of the Paediatric Regulation.
Speaker(s)
New GVP – Population-Specific Considerations, Paediatric Population
Jolanta Gulbinovic
State Medicines Control Agency , Lithuania
Chief Expert in Drug Safety; PRAC Member
Industry Experience to Pharmacovigilance / Risk Management in Paediatrics
Jacqueline Phillips, MD, MBA
Child Health Innovation Leadership Department (CHILD), Johnson & Johnson, United States
Director, Pediatric Product Development
The Patient Registry Initiative and Paediatric Aspects
Patricia McGettigan, DrMed, MD
European Medicines Agency, Netherlands
Clinical Pharmacologist, Pharmacoepidemiology Group
Upcoming New Clinical Trials Regulation
Seán Kilbride, PhD
Health Products Regulatory Authority (HPRA), Ireland
Assessor (Clinical Assessment)
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