DIA/EFGCP/EMA Conference on How to Optimise Children’s Access to Innovative Medicines

United in the goal of increasing the availability of new medicines to paediatric patients, how can we leverage examples from past successes to overcome future barriers?

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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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