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Executive Director formalises new high-level group

The European Medicines Agency has formally launched its new Scientific Coordination Board. The mission of the group will be to ensure that there is sufficient coordination between the committees, so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment.

The Agency’s Executive Director, Guido Rasi, said: “The current system of scientific committees, their working parties and other advisory groups has become increasingly complex.

We now have six scientific committees, plus two scientific advice working parties, one for human, one for veterinary medicines. Soon, in July 2012, we will see the establishment of a seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC). The complexity of the system has increased to a point where we have to ask ourselves if it is still fit for purpose. We have set up this new group so that we can analyse together the working methodology of the system so far, identify weaknesses or gaps in the system and discuss ways to address these.”

The group, which is chaired by the Agency’s Executive Director, is composed of the chairs of the Agency’s scientific committees, the scientific advice working parties and relevant senior management staff from the Agency’s secretariat. Following a first preparatory meeting in January 2012, the group has now been formalised. It will meet four times a year. Its mandate is to come up with a vision that integrates the expertise of all of the Agency’s committees into one common framework. The group will not deal with any issues related to specific medicines.

In addition to the challenges of coordinating a growing number of scientific committees with different roles, the group will also look at other factors that are putting the system under pressure. These include: increasing difficulties in sourcing appropriate experts due to the continuous strengthening of the rules on allowable conflicts of interests of the Agency’s experts; the continuous increase in the number and level of activities for all committees; and finally, challenges from new scientific developments, for instance advanced therapies or personalised medicines, which require an integrated scientific and regulatory approach, from the drug development phase, starting with scientific advice, right through to post-authorisation follow-up.

2016-12-11T18:42:24+00:0027.04.2012|Farmacovigilancia, Asuntos Regulatorios|