Regulatory Focus™ > News Articles > EMA Launches New Board to Coordinate Committees' Scientific Standards

EMA Launches New Board to Coordinate Committees' Scientific Standards

Posted 25 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced the launch of a new Scientific Coordination Board (SCB) which is intended to coordinate the development and implementation of standards between its committees.

The board, which was announced 25 April, aims to make it "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," EMA said in a statement.

"The current system of scientific committees, their working parties and other advisory groups has become increasingly complex," commented EMA's Executive Director, Guido Rasi. "We now have six scientific committees, plus two scientific advice working parties, one for human [and] one for veterinary medicines," with the Pharmacovigilance Risk Assessment Committee to launch in July 2012.

"We have set up this new group so that we can analyze together the working methodology of the system so far, identify weaknesses or gaps in the system and discuss ways to address these."

The SCB will be chaired by Rasi, with other members to include the chairs of EMA's scientific committees, scientific advice working parties and other EMA senior staff.

The group has already reportedly met once in January 2012, and will henceforth meet four times per year, EMA wrote in a statement.

Said EMA: "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
  • challenges from new scientific developments

Read more:

EMA - European Medicines Agency's Scientific Coordination Board starts reflection on best cooperation between scientific committees

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