The European Medicines Agency's Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) Coordinating Group, meeting online on 8 April 2026, discussed preparations for an expanded remit under the upcoming EU pharmaceutical legislation, which is expected to strengthen Enpr-EMA's role in addressing unmet medical needs and development prioritisation. The group also reviewed progress on a multi-stakeholder workshop on paediatric clinical trials scheduled for 12 May 2026, and explored practical steps to raise awareness and disseminate outputs, including the adoption of the hashtag #EnprEMA for social media.
The meeting, chaired by Ricardo Fernandes and Gunter Egger, began with an update on the upcoming EnprEMA & ACT EU workshop on paediatric clinical trials, to be held on 12 May 2026. Key sessions will be moderated by Monique Al and Annette Solli Karlsen, with breakout sessions on platform trials, patient recruitment and engagement, and innovative trial methodologies led by Pamela Kearns, Marek Migdal, and Dominik Karres. The workshop is seen as an important opportunity for EnprEMA to contribute to ACT EU activities and influence ongoing and future initiatives.
Gunter Egger provided an update on preparations for the revised EU pharmaceutical legislation, which is expected to expand EnprEMA's remit, including a stronger role in discussions on unmet medical needs and development prioritisation. This anticipated change will prompt a review and update of EnprEMA's governance documentation, including the mandate of the Coordinating Group, with most work expected to progress in the second half of the year. Work is also underway to strengthen EnprEMA's web presence, with a full website redevelopment planned for next year, subject to approval. An update on the member networks database noted that a new version was launched earlier this year, with several technical issues being addressed, and networks were reminded to update their self-assessments.
Ricardo Fernandes led a discussion on practical steps to strengthen EnprEMA's visibility and dissemination of outputs. Members shared practices such as audience-adapted communication, newsletters, webinars, and social-media hashtags, noting challenges of information overload and duplication across channels. A two-tiered communication model was proposed: real-time alerts for time-critical items and a periodic newsletter for broader updates. Participants agreed this approach could improve impact while reducing email fatigue. The importance of audience-specific materials was emphasised, and it was suggested to offer open webinars and workshops to help trial teams better understand regulatory aspects. The hashtag #EnprEMA has now been adopted for social media communications.
Isabel Sanchez presented updates from EnprEMA's working groups. The cross-border clinical trials group has published two papers on cross-border paediatric research, with additional manuscripts under review. Analysis of CTIS data is ongoing, and recommendations aimed at preventing language-related exclusion in paediatric trials are expected to be published soon. The paediatric research nurse group conducted a survey of research nurses and managers, with findings consolidated into a report to be published on the EnprEMA website. The Patient and Public Involvement (PPI) and Young Person's Advisory Groups (YPAG) working group is mapping current PPI capacity through a stakeholder questionnaire to be launched in June 2026, with results analysed over the summer and follow-up actions planned for October.
The meeting's discussions have implications for several stakeholders. For paediatric patients and their families, the expanded remit and focus on unmet medical needs could lead to more targeted development of treatments for rare diseases and conditions with limited therapeutic options. Clinical trial sponsors and research networks may benefit from improved guidance on cross-border trials and innovative methodologies, potentially reducing administrative burdens and enhancing patient recruitment. However, the anticipated governance updates and website redevelopment may require additional resources from EnprEMA member networks, who will need to update self-assessments and adapt to new communication channels. The emphasis on audience-specific materials and open webinars could help trial teams navigate regulatory complexities, but the challenge of information overload remains, as members noted duplication across channels.