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EMA gives details of new 'future-proof' structure

Will divide into four key areas covering R&D, medicines evaluation, business support and pharmacovigilance

The European Medicines Agency (EMA) has started a shake-up of its operating structure as it adapts to the evolving demands of its regulatory function.

The agency said last month it will soon be divided into four key areas covering R&D, medicines evaluation, business support and inspections/pharmacovigilance.

The new structure will "enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges", according to EMA executive director Guido Rasi.

The new divisional structure will guide a top-to-toe revamp of the EMA's operating processes that "introduces a new operating model for how medicines are managed through their entire lifecycle at the Agency, with separation of the scientific and procedure management", said the agency.

The changes are in part a response to the "increasing number and complexity of applications" being handled by the EMA's advisory committees, it added.

Earlier this year the EMA said in its annual report for 2012 that the total number of marketing authorisation applications it received was in line with previous years, but were marked by complex medicines such as the first gene therapy, namely UniQure's Glybera (alipogene tiparvovec).

At the time, the EMA noted that a lesson learnt from the Glybera review was that the agency needed to create a more adaptive regulatory framework for new medicines.

The transition to the new structure will take several months to implement but should complete before the end of 2014, according to the regulator.

This week the EMA has revealed the organisational chart for the new structure, including the heads of the new operating divisions.  The R&D unit will be headed by Zaïde Frias and evaluation will be led by Enrica Alteri, while Alexis Nolte will take the helm of the business support team and Fergus Sweeney will be in charge of inspections and pharmacovigilance.

The agency stressed that the changes will ensure continuity of operations, which means applicants, marketing authorisation holders and other stakeholders should continue working with their current agency liaison staff and product team leaders.

Among other changes revealed this week, a single division handling veterinary medicines and animal health will be created, while the advisory team will be bolstered with two new appointments. Noël Wathion takes up the role of chief policy advisor, while Agnès Saint Raymond will head a new programme design board.

Article by
Phil Taylor

18th September 2013

From: Sales, Regulatory, Healthcare



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