EMA To Hold Pediatric Medicines Workshop

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-11-2015 13:37


The European Medicines Agency's Enpr-EMA, a network of research networks, investigators and centers with expertise in performing clinical studies in children, will hold its seventh annual workshop on May 28, 2015, at the EMA. The aim of the annual workshop is to promote the conduct of high quality pediatric clinical studies.

The first day of the workshop will be open to all stakeholders, including patients/parents organizations, regulators, Enpr-EMA network representatives, academia, clinical investigators and representatives from pharmaceutical industry for pediatric studies. Participants will be informed of the latest developments of the Enpr-EMA’s activities to foster high-quality research in the area of pediatric 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 pediatric medicines and pediatric clinical trial programs in the various activities of the EMA. Also, to be discussed is a 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 as well as a basis for an action plan for 2015 that was discussed in a meeting held at the EMA on March 17, 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.

Source: European Medicines Agency


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