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The European Medicines Agency's (EMA) former leader has officially returned to head the agency today, after being forced to step down from his previous appointment last November.
With today's announcement, Professor Guido Rasi begins a new five-year term as EMA's executive director.
In November 2014, the EU Civil Service Tribunal annulled Rasi's appointment after Emil Hristov, former head of the Bulgarian Drug Agency, challenged the appointment process used by the European Commission that led to Rasi's appointment.
Both EMA and the European Commission appealed the tribunal's decision to the European Court of Justice.
During the interim, Andreas Pott served as acting executive director, while Rasi was offered a position as principle advisor in charge of strategy for the agency.
In October, EMA's Management Board nominated Rasi to once again be the agency's executive director. Rasi was appointed to the position following a two-hour hearing (video) by the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI).
During the hearing, Rasi outlined his vision for the future of healthcare and medicines regulation in europe: "I think for decades, medicine has been regulated in … isolation. The reality today is that regulators have to work with [so] many stakeholders and other communities along the process: researchers, companies, investors, healthcare technology assessment (HTA) bodies, payors, and most importantly patients and healthcare professionals. We are really collaborating intensively with many of these, but maybe now is the time to move from collaboration to integration to … get earlier and better medicine to patients."
On his re-appointment, Rasi said, "We are currently undergoing the most significant transformation of the system of medicine development and authorisation that I have seen during my 35-year career in public health, either as a doctor, a researcher or a regulator. It is exciting and challenging to be leading the Agency during this time."
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