From paediatric clinical trials and patient involvement to medicines regulation, AI and paediatric oncology, there are several opportunities to contribute, participate and stay informed over the coming months.
The minutes of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Coordinating Group meetings held in April and June 2026 are now available on the European Medicines Agency website.
UNICEF’s Europe and Central Asia Regional Office, in cooperation with the European Commission’s Directorate-General for Health and Food Safety, is developing a new Digital Toolkit for Child and Adolescent Health and Mental Wellbeing Promotion. The toolkit is intended to support evidence-informed policymaking across EU Member States, Iceland and Norway. It will bring together policy guidance, evidence, practical tools and examples of good practice across five areas:
The training provides participants with practical insight into how healthcare professionals and other stakeholders can contribute to EMA activities, including scientific advice, expert groups, document reviews and committee consultations.
The programme includes two online sessions:
The training is intended for representatives who have not previously participated in EMA annual training. Eligible organisations may propose one participant, who should be resident in the EU/EEA and able to participate in discussions in English.
Registration deadline: 10 August 2026
The training provides participants with practical insight into how healthcare professionals and other stakeholders can contribute to EMA activities, including scientific advice, expert groups, document reviews and committee consultations.
UNICEF’s Europe and Central Asia Regional Office, in cooperation with the European Commission’s Directorate-General for Health and Food Safety, is developing a new Digital Toolkit for Child and Adolescent Health and Mental Wellbeing Promotion. The toolkit is intended to support evidence-informed policymaking across EU Member States, Iceland and Norway. It will bring together policy guidance, evidence, practical tools and examples of good practice across five areas:
The workshop will support the development of a future reflection paper on proof-of-concept data for the development of anti-cancer medicines in paediatric patients.
Discussions will consider stakeholder feedback, evidence requirements and practical challenges in paediatric oncology drug development. The programme will also explore how lessons from oncology may help inform mechanism-of-action-based paediatric medicines development in other therapeutic areas.
Participants can register and submit questions until 18 September 2026.
The European Network of Paediatric Research at the EMA (Enpr-EMA) is inviting comments on its draft recommendations, Cross-border access to paediatric clinical trials in Europe: preventing language exclusion.
The recommendations examine how language and logistical barriers can restrict children’s participation in clinical research across Europe. Challenges include insufficient translation resources, limited availability of validated translated study materials and language requirements that may prevent children from accessing innovative therapies, particularly in rare diseases where participation may require travel to another country.
Clinical trial sites, investigators, research networks, sponsors, patient organisations and families are invited to contribute their perspectives.
Completed consultation templates should be sent to [email protected].
The Enpr-EMA Working Group on Patient and Public Involvement (PPI) is mapping PPI capabilities in paediatric research across Europe and the UK.
The survey aims to better understand how patients and caregivers are currently involved in paediatric clinical research and medicines development, and to identify gaps and future needs in areas such as training, tools and support.
The questionnaire is primarily aimed at academic research institutions and patient organisations and is available in English.
Survey deadline: 30 September 2026
Take part in the survey →
https://forms.office.com/e/RK8Bf5LYBP?origin=lprLink
For questions, contact Segolene Gaillard, Chair of the Enpr-EMA PPI Working Group, at [email protected]
The EMA has opened a public consultation on an addendum to its guideline on the clinical investigation of medicinal products used in weight control, specifically addressing their investigation in the paediatric population.
The proposed guidance focuses on the clinical evaluation of medicines used for weight control in children, and stakeholders are invited to review the addendum and provide comments.
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
