European Medicines Agency launches new organisational structure
The European Medicines Agency has officially unveiled a package of changes to mark the launch of a new organisational structure and new visual identity.
The European Medicines Agency has officially unveiled a package of changes to mark the launch of a new organisational structure and new visual identity.
"We have to adapt to the change of the size of the Agency, the volume of applications and the complexity of the system, and we also have to consolidate role and responsibilities at various levels in the Agency," explained Patrick Le Courtois, head of the new Human Medicines Development and Evaluation Unit to the recent TOPRA meeting in London. "Finally we wanted to prepare for future trends, such as the importance of therapeutic areas, the new legislation on pharmacovigilance and the growing number of international collaborations.
The reorganisation considered all the internal and external factors affecting the Agency's work and consolidates the internal process for all its procedures. It is also aimed at completing the Road Map to 2010 and preparing for the Road Map to 2015, including future changes such as pharmacovigilance legislation and emerging sciences.
One of the major changes is the integration of human pre- and post-authorisation activities into one unit, to guarantee seamless lifecycle management of medicines. It will be 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.
A new unit for patient health protection, led by Noel Wathion, has been created to further strengthen the Agency's focus on safety monitoring of medicines. In addition, a dedicated group for the management of product data and documentation will improve the efficiency of data management processes throughout the Agency.
A fourth layer of management has been set up: section heads will now report to the Heads of Sector and will have full managerial responsibility.
Meanwhile, a new visual identity will help to promote public recognition of the Agency and its contribution to public and animal health, and a new website has also been launched, offering improved navigation and search functionality, providing better access to information on public-health issues.
Welcoming the changes, the Agency's executive director, Thomas Loenngren, said: "The new structure reinforces our operational ability to deliver on our increasingly complex tasks, and our new visual identity will help to improve the quality and consistency of our communications with our partners and the public."