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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.

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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.

EFGCP EMA DIA

Featured topics

  • Update on PDCO/EMA initiatives
  • Extrapolation and Modelling & Simulation
  • International collaboration
  • Patients’ and Healthcare professional’s voice
  • Q&A on regulatory questions
  • Break-out sessions

Who should attend?

  • Regulatory, clinical and drug development professionals from Health Authorities and Industry
  • Paediatricians, Representatives from Academia, Paediatric Societies and Networks Employees from Clinical Research Organisations (CROs) involved in paediatric clinical trials
  • Any stakeholder interested in the development of better medicines for children

Learning objectives

  • Update participants on current paediatric regulatory requirements, scientific and operational success and challenges
  • Exchange experiences with regulatory authorities, academia and industry
  • Discuss visions, daily challenges and potential ways to move forward and further improve processes for paediatric drug development

Program Committee

  • Gesine  Bejeuhr, PharmD
    Gesine Bejeuhr, PharmD Pediatric Regulatory Leader
    Bayer AG, Germany
  • Emilie  Desfontaine
    Emilie Desfontaine Scientific Officer
    European Medicines Agency, Netherlands
  • Mette  Due Theilade Thomsen, PhD
    Mette Due Theilade Thomsen, PhD Managing Director
    PIP Adviser, Denmark
  • Andrea  Ecker
    Andrea Ecker Scientific Officer, Paediatric Medicines Office
    European Medicines Agency, Netherlands
  • Detlef  Niese, DrMed, MD, RPh
    Detlef Niese, DrMed, MD, RPh Consultant
    Dr.Niese Health Science & Policy, Germany
  • Florian  Schmidt, JD, LLM
    Florian Schmidt, JD, LLM Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
    DG SANTE, European Commission, Belgium
  • Paolo  Tomasi, MD, PhD
    Paolo Tomasi, MD, PhD Head of Paediatric Medicines
    European Medicines Agency, Netherlands
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Registration Questions

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+41 61 225 51 51



Agenda and Logistics Questions

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+41 61 225 51 49


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