This year, in 2020, 13 years after the EU Paediatric Regulation came into force, our aim is to build on achievements and lessons learnt so far and to look at the future of paediatric drug development, with a specific focus on putting patients at the heart of innovation and regulatory science.

The opening panel session moderated by Fabio d'Atri (DG SANTE, European Commission) and involving key speakers representing EMA, FDA, National Authorities, Healthcare Professionals, and Industry, will be the opportunity to share updates in the field and discuss the future of the development of paediatric medicines: what to do more to be better at delivering innovations to children in needs? How the EC/EMA action plan has been progressed?

To give them even more attention, in a separate panel session, the Young Patients, will tell us what the future of paediatric drug development means and looks like for them.

Active engagement of conference participants is expected to discuss challenges and identify solutions on what could be done to optimise children’s access to new medicines:

1. What data sources and digital technologies could bring to paediatric development on top of the use of extrapolation?
2. How to best define children unmet medical needs?
3. How to optimise the PIP process and regulatory approval

A fireside chat with PDCO moderated by Elin Haf Davies (Aparito) and involving the PDCO chair & vice-chair, will give the audience the opportunity not only to understand PDCO's specific activities and priorities but also to further address clarifying questions to PDCO members.

The value of multi-stakeholder collaborations has been shown, since an opportunity to address important scientific gaps, but what is ongoing to foster paediatric development?

The conference will also explore what drug development means for Paediatricians, and in particular during COVID-19 pandemic.