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PIP Focusing on Child-Centric Medicines Developments
Session Chair(s)
Gesine Bejeuhr, PharmD
Pediatric Regulatory Leader
Bayer AG, Germany
Chrissi Pallidis, DrMed
Senior Scientific Specialist, Paediatric Medicines
Scientific Evidence Generation Department, European Medicines Agency, Netherlands
Several programmes to further boost child-centric medicines’ development have been implemented or are currently being discussed. The general principles of the concept of a stepwise PIP are described and experience from the implementation of the pilot which was launched in February 2023 will be shared. The session will also explore if and how Mechanism of Action-PIP could work beyond oncology.
Learning Objective : Regulatory aspects of and necessary prerequisites for paediatric-centric drug development through Mechanism of Action/ Molecular target PIPs will be explored by a panel of experts with views from regulators, patients, clinicians and industry. It will be identified how paediatric needs can be best addressed by applying scientific evidence while global convergence is being considered.
Speaker(s)
How to Meet Paediatric Needs Through Innovative Development Strategies?
Gesine Bejeuhr, PharmD
Bayer AG, Germany
Pediatric Regulatory Leader
Evolving Paediatric Development Strategies and the Role of Step-Wise PIPs
Chrissi Pallidis, DrMed
Scientific Evidence Generation Department, European Medicines Agency, Netherlands
Senior Scientific Specialist, Paediatric Medicines
Panelist
Brian Aylward
Health Products Regularity Authority, United Kingdom
Clinical Assessor & Chair of the PDCO FWG, EMA
Panelist
Mariska Mulder, PharmD
Ultragenyx Netherlands BV, Netherlands
Head of Regulatory Affairs, EMEA, LATAM & Marketed Products
Panelist
Tomasz Grybek
Fundacja Bohatera Borysa, Poland
Patient Representative
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