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BMFC2026 Programme

Under the theme “Collaborating to Implement Innovative Approaches in Paediatric Development” this year’s Conference offers a wide variety of sessions for attendees, and will feature distinguished speakers from all around the world, relevant stakeholders and experts, to delve into the latest innovations in paediatrics.

Day One will explore the evolving ethical and regulatory landscape in paediatric medicine development, alongside sessions on clinical research, innovation, and collaborative discussion through interactive breakout sessions. The day will conclude with expert insights and networking opportunities.

Day Two will focus on key takeaways from the breakout sessions, emerging innovations in paediatric drug development, and discussions on medical devices, global regulatory developments, and advances in rare diseases and cell and gene therapies.

The conference provides an opportunity to share knowledge, exchange ideas, and connect with experts and stakeholders from across the global paediatric development community.

Day 1

09:00 Welcome Coffee / Registration


10:00 Keynote: Evolution of ethical paradigms in paediatrics through the revised declaration of Helsinki


10:30 Challenges and opportunities for paediatric drug development in Heart diseases


11:30 Mechanism of Action – Impact for Paediatric Investigational Plans and children


12:45 Lunch Break


13:45 Advances in Europe’s Clinical Research Ecosystem


15:00 Coffee Break


15:20 Breakout sessions:

  • Implementation of new PIP requirements
  • Innovative approaches to develop age-appropriate formulations
  • Operational opportunities to bring trials to children

16:40 Coffee Break


16:50 Market Access / HTA – experience with Joint Clinical Assessment of paediatric medicines


18:00 Fireside chat with PDCO Chair


18:30 End of the Day

Day 2

08:15 Welcome Coffee / Registration


08:45 Break-out session reports


09:30 New Voices – what is new in paediatric drug research


10:30 Coffee Break


11:00 Achievements in rare diseases and Cell & Gene Therapies


12:00 Lunch Break


13:00 Global regulatory alignment and feedback from regulatory agencies


14:15 The future of paediatric Medical Devices, In-vitro Diagnostics, and Combination products


15:15 Wrap-up and Farewell


15:30 End of the Conference