close

Global Paediatric Drug Development: the value of multi-stakeholders’ collaboration Amsterdam

Join the EFGCP PAEDIATRIC CONFERENCE 2023 - Better Medicines for Children: “Global Paediatric Drug Development: the value of multi-stakeholders’ collaboration”, taking place in Amsterdam on the 17th and 18th of October 2023.

The conference will focus on Multi-stakeholders’ collaboration, its challenges and solutions, and in particular its value, with a focus on what has been achieved in Europe, in the US and globally, whether for example, through Public-Private Partnerships, e.g., the EU Innovative Health Initiative or the US Critical Path Institute. To this effect, the conference will bring together not only distinguished speakers from all around the world but also all the relevant stakeholders and experts involved in paediatric drug development.

At this conference, you will have the opportunity to hear from the EU Commission where they are with the revision of Pharmaceutical Legislation and its impact of paediatric drug development. The stakeholders who have already used the Stepwise Paediatric Investigation Plan Pilot established by EMA in February 2023, will share their experience so far. Stakeholders from around the world will share their view on the value of multi-stakeholders’ collaboration, what can be learnt and what could be expected in the future to address unmet needs of underserved populations, such as neonates or those with rare diseases.

Active engagement of conference delegates will be then welcomed in Breakout Sessions to discuss
challenges and identify solutions on what could be done to optimise children’s access to new medicines, with a focus on important topics:
1. Inclusion of Adolescents in Adult Trials.
2. Data collection and Data sharing.
3. Paediatric Extrapolation: what progress has been made since 2022?

Hot paediatric topics for which multi-stakeholders’ collaboration is more than ever valued to address gaps in scientific knowledge and find synergies to optimise patients’ access to new medicines, will explore innovative development avenues that could foster paediatric drug development. A panel committed to finding solutions for rare diseases, which present a unique public health challenge, will discuss the latest information on rare diseases. Similarly, new initiatives will be discussed, and their respective panels will explain their strategy to deliver tangible and innovative changes, whether for neonates, for the selection of investigational sites through quality criteria and standards for paediatric trials, or for the implementation of a platform for the use of Paediatric Oncology RWE in regulatory and clinical decision making.