PRESS RELEASE
European Medicines Agency implements internal reorganisation

The European Medicines Agency has begun implementing a series of changes to its internal  organisation aimed at improving the functioning of the Agency and the way in which it delivers its  core tasks. The changes will be introduced gradually from September to December 2009.  In line with its increased responsibilities, the Agency has developed over the past years in terms of  staff numbers and internal processes. The number of scientific committees and the complexity of  procedures have also grown, and the cross-relationship between committees brings with it the need for enhanced coordination. In addition, future legislative proposals are expected to bring further responsibilities to the Agency.
Following an Agency-wide process improvement exercise initiated in 2006, from May 2007 attention focused specifically on core business – examining processes within the two units dealing with medicinal products for human use and monitoring their interactions in order to assess their potential for adapting to future needs.

• The resulting reorganisation includes the following key changes:
• The life-cycle management of medicines for human use is brought together into one Unit, HumanMedicines 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

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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