European Medicines Agency [to 26 March 2016]
http://www.ema.europa.eu/

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21/03/2016
EMA Management Board: highlights of March 2016 meeting
Christa Wirthumer-Hoche elected as new chair of the Management Board
At its 17 March meeting in London, the European Medicines Agency’s (EMA) Management Board elected Christa Wirthumer-Hoche as chair of the Board for a three-year period. Dr Wirthumer-Hoche is Head of the Austrian Medicines and Medical Devices Agency, a post she has held since October 2013. She has served as vice-chair of EMA’s Management Board since March 2015. For further information, please see separate announcement.

Medicines for children: achievements and challenges
Dr Dirk Mentzer, chair of EMA’s Paediatric Committee (PDCO) and Head of Pharmacovigilance at the German national agency for vaccine and biomedicinal products (Paul-Ehrlich-Institut), presented the achievements, challenges and priorities of the PDCO regarding medicines for children.

The chair recalled that the EU Paediatric Regulation came into force 10 years ago to improve the health of children in Europe by stimulating high quality research and promoting the development and authorisation of paediatric medicines in the EU.

Dr Mentzer highlighted areas where the therapeutic landscape for children has significantly improved over the past few years. These include rheumatologic diseases, conditions that affect the joints, muscles, bones and immune system, for which children had extremely limited therapeutic options a few years ago. “Thanks to the EU Paediatric Regulation which has enforced the study of new innovative treatments in paediatric rheumatology, a number of biological medicines for rheumatologic conditions are now authorised for use in children,” explained Dr Mentzer. “Children also have access to new and innovative treatments for hypertension and hypercholesterolaemia as well as for infectious diseases, such as HIV and hepatitis C. All these medicines were authorised on the basis of studies conducted as part of paediatric investigation plans (PIP) agreed with the PDCO.”

Dirk Mentzer mentioned ongoing challenges in areas such as neonatology, neurology, congenital defects and paediatric rare cancers in which it is difficult to study medicines, in particular due to the rarity of these children-only indications or the high toxicity of the medicines, e.g. in cancer.

In future, the PDCO will focus on the integration of innovative clinical trial methodology, such as modelling, simulation and extrapolation of data, in its decisions. “These tools are very helpful to avoid unnecessary studies in children, one of the objectives of the Paediatric Regulation,” explained Dirk Mentzer. Strengthening collaboration between EMA committees and increasing the involvement of patients in PIP decisions, for example to collect their views on the feasibility of clinical trials, are also among the PDCO’s key priorities for the years ahead…