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The life-cycle management of medicines for human use is brought together into one Unit, Human Medicines Development and Evaluation, led by Patrick Le Courtois and responsible for the provision of advice during R&D, through to management of the review process and changes to products after they have been approved
The creation of a Unit, Patient Health Protection, led by Noël Wathion, contributing to patient health protection from the multiple perspectives of pharmacovigilance, risk and crisis management, patient and health care professional information, inspections (for both human and veterinary products), and appropriate regulatory compliance. The Unit will also be in charge of community procedures for both centrally and non-centrally authorised products
Within the Unit for Veterinary Medicines and Product Data Management, led by David Mackay
- creation of a single Sector responsible for all areas of veterinary medicines - development, evaluation and maintenance of veterinary medicines, public and animal health (including safety) and veterinary regulatory affairs
- creation of a single Sector for the management of product data and documentation related to applications for the whole Agency; it will also be involved in the development of IT systems to support scientific business processes Rationalisation of services within the Unit for Information and Communications Technology, led by Hans-Georg Wagner and within the Administration Unit, led by Andreas Pott