EFGCP Better Medicines for Children Conference 2026
Collaborating to Implement Innovative Approaches in Paediatric Development
Description
The EFGCP “Better Medicines for Children” Conference is an annual premier event that offers a unique platform to share best practices, reflect on developments since our last meeting in October 2025, and explore paediatric updates and opportunities arising through the European legislation, important scientific innovations and paradigm shifts.
The theme for 2026 is “Collaborating to Implement Innovative Approaches in Paediatric Development”. This conference will convene distinguished speakers from all around the world, relevant stakeholders and experts, to delve into the latest innovations in paediatrics. It will address practical questions on how the revised European General Pharmaceutical Legislation and other initiatives such as the EU Biotech Act should be implemented to achieve the best outcomes for children living with health conditions and their families in the most effective manner.
Day One will open with a keynote address on ‘The Revised Declaration of Helsinki – Evolution of Ethical Paradigms in Paediatrics.’ The program will then feature sessions dedicated to heart diseases, mechanism-of-action-driven paediatric developments, and an in-depth look at the EU clinical research ecosystem.
Breakout Sessions encourage participants to actively share views and practical examples on:
1. Implementation of new PIP requirements
2. Innovative approaches to develop age-appropriate formulations
3. Operational opportunities to bring trials to children
A session on Market Access and Health Technology Assessment (HTA) experiences with joint clinical assessments of paediatric medicines will delve into another critical aspect. The day will conclude with a fireside chat with the PDCO Chair and opportunities for networking.
Day Two will start with the feedback and key deliverables from the Breakout Sessions. The New Voices’ segment will highlight practical examples of paediatric drug development driven by innovative initiatives. In addition, We will then explore the important role of medical devices, in‑vitro diagnostics (IVDs), and EU/US combination products in paediatric treatments. These sessions will be followed by discussions on the global regulatory landscape, regulatory convergence, and successful developments in rare diseases and cell & gene therapy.
This event offers a unique opportunity to exchange knowledge, share insights, and connect with experienced colleagues and leading experts from around the world.
While the conference will once again offer a hybrid format, we strongly encourage you to join us in person. Attending the event onsite provides an excellent opportunity to engage directly with key stakeholders in paediatric drug development and to build valuable connections with fellow delegates.
Development of paediatric medicines requires strong partnerships and collaboration between all relevant partners around the world, and we are looking forward to welcome you to the conference!
Early Bird Fees available until May 30, 2026!
Online attendance will be view only. There will be no direct interaction with on site faculty.
Programme
| 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 |
| 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 |
