20 years of progress in medicines regulatory science

Image: European Medicines Agency's 20th anniversary conference © EPF

EPF President Anders Olauson attended the European Medicines Agency (EMA)'s 20th anniversary conference on 18 March. Entitled 'Science, Medicines, Health: Patients at the heart of future innovation', the event captured changes and progress in medicines regulatory science over the past 20 years.

“It is impressive to see what the EMA has accomplished over the past 20 years. The Agency has been taking the involvement of patient organisations very seriously into account and we are delighted to see that patients’ representatives were engaged through a lot of EMA’s activities”, said Mr. Olauson.

Our close involvement with the Agency includes our representation in the Patient and Consumer Working Party since 2006 where we provide recommendations to EMA human scientific committees on all matters of interest to patients in relation to medicinal products.

EPF was also a member of the EMA’s Working Group on Clinical Trials in Third Countries and EMA’s Working Group on the EuraVigilance Medicines Safety Database in 2011-2012.

In 2013-2014, patients were also represented on the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) for the first time. EPF was proud to see one of our board members, Marco Greco, sitting on this Committee responsible for assessing and monitoring safety issues for human medicines.

Elia Zerhouni, President of Global R&D, at Sanofi, mentioned his ‘turning the Titanic’ publication at the Anniversary event. He explained how, according to him, the R&D engine must be redirected toward deciphering the natural histories of human diseases and using this knowledge to select therapeutic targets. More generally the major concern raised at the event related to the harmonisation of regulatory bodies within the 28 member states.

More information: http://www.ema.europa.eu/ema/