European Network of Paediatric Research at the European Medicines Agency introduced to wider audience
The EMA has held a two-day workshop to introduce the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) to a wider audience.
Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children, which aims to foster high-quality ethical research on quality, safety and efficacy of medicines to be used in children.
The first day of the third workshop on Enpr-EMA was dedicated to discussions between networks. Its main achievement was the establishment of Enpr-EMA's co-ordinating group with the network's full 'category 1' members. The group's priorities include establishing Enpr-EMA as a platform for communication with industry and patient organisations and for linking activities between Enpr-EMA's members, to improve co-ordination of studies in paediatric medicine and avoid unnecessary testing in children.
The workshop elected Professor Peter Helms as chair of the co-ordinating group. Prof. Helms is Professor of Child Health at the University of Aberdeen and Director of the Scottish Medicines for Children Network.
The workshop's second day introduced the network to all stakeholders, particularly patient organisations, clinical researchers and pharmaceutical industry staff responsible for paediatric studies. The workshop heard representatives from Enpr-EMA, from the pharmaceutical industry and from patient organisations explain their expectations for the network. The pharmaceutical industry was represented by large pharmaceutical companies, as well as companies developing medicines for rare diseases and small and medium-sized enterprises (SMEs).
In three break-out sessions, workshop participants discussed proposals for the role and input of the stakeholders involved in the Enpr-EMA initiative.
The Agency will publish presentations and a video recording from the second day of the workshop later this year.
The second day of the workshop was organised with the assistance of The Organisation for Professionals in Regulatory Affairs (TOPRA).