EMA Has Implemented Changes to its Organisational Structure

The purpose of the re-organisation is to ensure that the Agency operates as efficiently as possible to deliver high quality outputs for public and animal health. The exercise takes into account the rapidly evolving landscape for pharmaceutical research and development that requires regulators to keep up with advances in science and technology and prepare for future challenges at an ever-accelerating pace.

The change is also driven by the need to recalibrate to a lower head count following the relocation of the Agency to Amsterdam in 2019 whilst dealing with an increased workload due the implementation of various new pieces of legislation.

“These organisational changes will strengthen our ability to carry out important new activities together with our partners in the European medicines regulatory network and tackle the important opportunities and challenges that lie ahead, such as analysis of healthcare data, digitalisation and new scientific methods and technologies,” said EMA’s Executive Director Guido Rasi. “It will also ensure that we are geared up for the future with more efficient processes firmly rooted in data and digital technology to keep pace with rapid advances in science.”

The main, high-level changes are as follows:

Operations in the area of human medicines have been integrated into one Human Medicines Division, which will be led by Alexis Nolte. The structure of the Veterinary Medicines Division, under the leadership of Ivo Claassen, remains unchanged.

In addition, four mission-critical task forces have been established to support the human and veterinary medicines divisions, bringing together expertise to drive transformational change in the following high-priority areas:

• The Digital Business Tansformation task force will be responsible for driving complex, digital change initiatives that impact on the strategy of EMA, its structure and operations in relation to the network, its partners and stakeholders. It will include adapting EMA operations to fundamental changes brought by legislative initiatives, digital technologies and global trends to meet stakeholders’ needs and expectations. Zaide Frias will lead this taskforce.
• The Data Analytics and Methods task force will be responsible for building up capability and capacity within EMA and across the network, to deliver robust evidence for benefit-risk decision-making. This will be achieved through expert scientific advice on products under development, through strengthened support to marketing authorisation assessments and through expert methods advice and data analysis for medicines on the market. Peter Arlett will head this taskforce.
• The Regulatory Science and Innovation task force will enable the continuous ‘future-proofing’ of the Agency and the network by addressing key scientific and technological trends and their translation through the development of EMA’s regulatory science strategy, planning and governance. It will also seek to offer an enhanced first point of contact service to developers, in particular small and medium-sized enterprises (SMEs) and academia. This taskforce will be led by Anthony Humphreys.
• The Clinical Studies and Manufacturing task force will be responsible for developing and guiding Agency strategy at EU and global level to support the facilitation of clinical studies and manufacturing. Fergus Sweeney will lead this taskforce.

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