Overview
Nearing a decade of the EU Paediatric Regulation, with close to 2,000 submitted Paediatric Investigation Plans (PIPs), paediatric needs are recognised as an integrated part of drug development, with the inclusion of children now accepted as standard procedure. However, challenges remain, which can result in delayed access by children to innovative medicines.
This year’s DIA/EFGCP/EMA annual paediatric conference will focus on ways to overcome these challenges, such as through collaboration, extrapolation, modelling & simulation and adaptive pathways. This is the conference to interact with EMA paediatric coordinators, Paediatric Committee (PDCO) members and other stakeholders interested in paediatric drug development. Patients’ and Healthcare professional’s views will complement the reports of practical experience.
In addition you have the possibility to send your question already beforehand to be sure that the topic will be addressed during the conference.
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Program Committee
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Gesine Bejeuhr, PharmD Pediatric Regulatory Leader
Bayer AG, Germany -
Emilie Desfontaine Operational Investor
Jeito Capital, France -
Mette Due Theilade Thomsen, PhD CEO
PIP Adviser, Denmark -
Andrea Ecker Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands -
Detlef Niese, DrMed, MD, RPh Visiting Lecturer
University Freiburg Inst. F.Pharmaceutical Sciences, Germany -
Florian Schmidt, JD, LLM Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
DG SANTE, European Commission, Belgium -
Paolo Tomasi, MD, PhD Head of Paediatric Medicines
European Medicines Agency, Netherlands
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