EMA Board Endorses 'Road Map to 2015' - Pharmaceutical Technology

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EMA Board Endorses 'Road Map to 2015'


ePT--the Electronic Newsletter of Pharmaceutical Technology

After announcing the official appointment of Guido Rasi as new executive director, the EMA management board also endorsed the implementation plan for the agency’s ‘Road map to 2015’ in a press statement released Oct. 7, 2011.

The implementation plan provides information on how the vision outlined in the road map can be developed, and has a strong focus on the operating efficiency of EMA’s core business activities over the next five years. Conducting itself in the framework of current and future legislation is fundamental to all of the agency’s activities, but, in addition, the road map will optimize performance in three strategic areas: addressing public health needs, facilitating access to medicines, and optimizing safe and rational use of medicines.

The press release also indicates a degree of sensitivity to the current economic climate, stating that the road map will be implemented gradually through annual work programs up to 2015.

The board welcomed progress on the implementation of the revised policy on the handling of conflicts of interest, which aims to achieve a more robust and transparent system. One of the measures in the new policy is a database, launched Sept. 30, 2011, that allows the public to access the declarations of interests of all nominated experts across the EU for the first time. Previously, such information was only available on request. Out of 5000 experts currently on file, only half have submitted new, signed declaration of interest forms. The remainder will be unable to participate in EMA activities, though no deadline was given for submission.

Finally, the EMA management board congratulated the agency on its increased involvement with patients’ and consumers’ organizations, citing, among other achievements, increased participation of patient experts in advisory group meetings and increased participation of patient representatives within the Pharmacovigilance Working Party. The board also adopted revised criteria to be fulfilled by patients’ and consumers’ organizations, which broaden involvement in scientific committees and increase transparency criterion for funding sources. The focus for the next two years will be on revising the ‘framework for interaction,’ which will include the involvement of patients in scientific committees and risk–benefit evaluations.

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