EMA readies paediatric trials network
pharmafile | May 14, 2010 | News story | Research and Development | EMA, EMEA, paediatric, paediatric trials
The European Medicines Agency is about to press the start button on its long-planned network for clinical studies in children.
The idea is that existing researchers, investigators and centres with relevant experience – from single speciality trials groups to those covering all paediatrics – will band together.
One of its main tasks will be to facilitate pharma industry access to paediatric clinical study centres and experts.
Those interested in joining the European Paediatric Research Network at the EMA (EnprEMA) have until the end of July to provide evidence of their ability to meet various criteria.
These are: research experience and ability, organisation and processes, scientific competencies and ability to provide expert advice, quality management, training and educational capacity, and public involvement.
“The agreement on the recognition criteria and the operational structure represents a milestone in getting this network off the ground,” said the EMA’s Agnès Saint-Raymond, who is responsible for medicines for children.
EnprEMA will in effect be run by a coordinating group which is expected to have its first meeting in the second half of the year.
The group will comprise a cross-section of up to 20 network members which have expertise in different therapy areas, age groups or activities such as pharmacovigilance.
It will also be responsible for identifying new networks not presently included in EnprEMA and encouraging children and parents to participate in clinical trials.
Representatives from 38 existing national research networks or clinical trials centres came up with the organisational structure for the European venture.
“We have a clear idea now what expertise and experience we are looking for in this network and how it is going to be run,” said Saint-Raymond.
She concluded: “What we have seen from working with the existing networks, investigators and clinical trials centres so far, has given us a lot of reasons to be confident that EnprEMA, with its emphasis on inter-network and stakeholder collaboration, will help fostering high-quality, ethical research of medicines in children.”
Adam Hill
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