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Conduct and Completion of Paediatric Development Plans, As Agreed in Paediatric Investigative Plans (PIPs) or Paediatric Study Plans (PSPs)
Session Chair(s)
Dirk Mentzer, DrMed, MD
PDCO Chair 2013-2019; Head of Pharmacovigilance Unit, Paul-Ehrlich-Institut, Germany
Paediatric medicinal product development has a number of challenges based on the specific, unchangeable aspect of the population. The focus of agencies and applicants should therefore be on the harmonisation of the requirements to achieve marketing authorisation in the respective regions and at the same time avoiding unnecessary trials across the regions and consequently reducing uncontrolled or off-label treatment of children.
Speaker(s)
Angelika Joos, MPharm
Consultant, Consultant, Belgium
Vision 2020: Paediatric Development as Integral Part of New R&D Models
Harris Dalymple
Senior Director Project Management, PPD, United Kingdom
PIP-Experienced CRO Perspective
Dawn Gbekor
, PPD, United Kingdom
PIP-Experienced CRO Perspective
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
Towards Better Medicines for Children – Exploring the Issues Relating to Off-Label Prescribing in the Paediatric Population
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