EMA – Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA): publication of the event’s materials of the 2024 annual meeting of the Enpr-EMA held the 1 October 2024 and of the 2024 Annual Workshop of the Enpr-EMA held the 2 October 2024
The annual meeting of the members of Coordinating Group and members of European network of paediatric research at the EMA (Enpr-EMA) 2024 brought together paediatric trial networks and other stakeholders of Enpr-EMA to discuss topics of common strategic interest and to provide an update on the progress of Enpr-EMA’s working groups.
Topics discussed included:
- updates from the working groups;
- discussion on new perspectives regarding Enpr-EMA;
- networks’ practical experiences and best practices regarding trial conduct.
The minutes and the presentation materials of the event are now available on the EMA Website.
Enpr-EMA’s annual workshop offers a unique platform for paediatric research networks as well as other stakeholders of paediatric clinical trials, such as health care professionals, parents, carers, patient representatives, medicine developers and regulators to gain insights into recent network activities and to learn about the latest developments supporting paediatric clinical research.
The workshop provides an open forum for discussions relevant to all stakeholders and aims to foster collaboration across networks and stakeholders, promoting clinical trials for medicines for children.
Key topics include:
- Recent network activities: Learn about the Enpr-EMA initiatives on quality criteria for paediatric clinical trial sites and on cross-border access to paediatric clinical trials; receive an introduction to new European paediatric clinical research infrastructure.
- Clinical Trial Regulation (CTR) and ethical aspects in paediatric trials: Discuss the CTR implementation, EU transparency rules and emerging ethics assessment challenges for paediatric trials and updates on the revision of the Declaration of Helsinki.
- Regulatory update: Learn about the proposed revised EU pharmaceutical legislation and its impact on paediatric medicine development, updates from the Paediatric Committee, and new methods to assess combination products (medicine/device).
- Health Technology Assessment: Focus on upcoming regulatory shifts and the use of Real-World Data, and how academia can support this effort.
The report and the presentation materials of the event are now available on the EMA Website.
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vroby (4 février 2025). EMA – Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA): publication of the event’s materials of the 2024 annual meeting of the Enpr-EMA held the 1 October 2024 and of the 2024 Annual Workshop of the Enpr-EMA held the 2 October 2024. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/138p6





