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Clinical Trial Events
DIA Europe

Talk Regulatory Strategy & EU Pharmaceutical Policy track

S0906 - Paediatric Medicines in the EU and Global Contexts: Latest Developments

Thu, Mar 20, 2025 · 8:30–9:40 AM CET Boston 1-2 Room, Congress Center Basel

About this session

The ongoing revision of the EU Pharmaceutical Legislation is an opportunity to assess the EU Paediatric system, discuss ways to improve its implementation and promote increased global regulator collaboration in developing medicines for children. This session will provide an overview of the latest developments in the revision of the EU Paediatric legislation and explore existing initiatives aimed at achieving global harmonisation of development programs with international partners. Furthermore, case studies will be presented to highlight how current approaches can be optimised.

Programme:
- 2. New adapted paediatric investigation plans (PIPs) and mechanism of action PIPs — Sara Escola
- Panel Discussion — Ralph Bax
- 3. Paediatric Regulation Revision in the EU - Industry view — Jyothsna Krishnan
- 4. Paediatric medicines in the EU and Global context: Latest developments — Ralph Bax
- 1. Setting the scene — Angelika Joos

Speakers

  • Angelika Joos

    Independent consultant · CRP International Strategy Consulting

    Chair

  • Jyothsna Krishnan

    Director, Regulatory Drug development & manufacturing · EFPIA

    Speaker

  • Ralph Bax

    Head of the Paediatric Medicines Office · European Medicines Agency

    Speaker

  • Sara Escola

    Regulatory Affairs Senior Manager · PTC Therapeutics

    Speaker