EMA looks to adapt to smaller workforce

While EMA’s staffing losses are in line with projections as it settles into its new Amsterdam headquarters, the agency said it plans to establish task forces to tackle key priorities such as regulatory science and cautioned that it will be challenging to implement planned legislation for veterinary medicines and medical devices due to resource constraints.

EMA's workforce has fallen to 730 from its December 2018 headcount of 901, representing a loss of 19%, according to the agency’s highlights from its Oct. 3 management board meeting. In June, the agency said it expects a 20-25% staff loss (see "Key Activities Still on Hold as EMA Ramps up in Amsterdam").

EMA's staff has dropped from 776 in June. At the time, the agency’s workforce had 312 remote workers. The agency said Friday that its interim arrangements for teleworking have now largely come to an end.

At the meeting, Executive Director Guido Rasi announced that to prepare for challenges with its existing workforce, the agency is reviewing its organizational structure and exploring use of task forces to focus on priorities, such as digital business transformation, data analytics and methods, regulatory science and innovation, as well as clinical trials and manufacturing strategy.

EMA also said it plans to integrate its human medicines operations "to strengthen the therapeutic focus all along a medicine's lifecycle, with the ultimate aim of assuring the quality of scientific opinions and further improving support to EMA's scientific committees." It did not provide details.

The agency expects to move into the new EMA building in Amsterdam Zuid the week of Jan. 13.

Data transparency

The agency also commented on two court cases involving data transparency that are pending before the Court of Justice, warning that “if the Court of Justice were to follow the recommendations set out in these opinions, EMA’s existing transparency policies would be impaired and have to be revised.”

PTC Therapeutics Inc. (NASDAQ:PTCT) and the animal health unit of Merck & Co. Inc. (NYSE:MRK) appealed a 2018 ruling by the court that no general presumption of confidentiality exists with respect to clinical study reports, and that such a disclosure of information would not compromise commercial interests.

Reviewing the appeal in September, Advocate General Gerard Hogan said he believed the court erred in its decision.

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