Promoting high quality scientific research in paediatric medicines
Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on 28 May 2015
Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at the EMA. The aim of the annual workshop is to promote the conduct of high quality paediatric clinical studies.
Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Its main objective is to facilitate studies in order to increase the availability of medicines authorised for use in children.
The first day of the workshop will be open to all stakeholders including patients/parents organisations, regulators, Enpr-EMA network representatives, academia, clinical investigators and representatives from pharmaceutical industry for paediatric studies.
Participants will be informed of the latest developments of the Enpr-EMA's activities to foster high-quality research in the area of paediatric medicine.
Among the highlights of this year's workshop are:
- discussions on the planned establishment in 2015 of a Young Persons Advisory Group (YPAG) as part of the EMA's Patients' and Consumers' Working Party (PCWP). The purpose of this group is to integrate the views and preferences of children and adolescents on paediatric medicines and paediatric clinical trial programmes in the various activities of the EMA;
- Recent EMA initiative to bring regulators and neonatologists together to address issues related to the development of medicines for neonates, including the design and conduct of clinical trials for these medicines; a basis for an action plan for 2015 was discussed in a meeting held at EMA on 17 March 2015.
The second day of the workshop is reserved for discussions among the members of Enpr-EMA and the Enpr-EMA coordinating group. The coordinating group will define priority tasks for 2015-2016 based on the feedback received from stakeholders.
Three new networks joined Enpr-EMA in 2014. Information about Enpr-EMA members is available in a fully searchable database established by EMA in 2014.
Enpr-EMA actions focus on:
- fostering high-quality, ethical research on the quality, safety and efficacy of medicines for use in children;
- helping with the recruitment of patients for clinical trials;
- enabling collaboration between networks and stakeholders;
- avoiding unnecessary duplication of studies;
- building up scientific and administrative competence at a European level;
- promoting European Commission framework programme applications.