1 Amendments of Marina YANNAKOUDAKIS related to 2008/0257(COD)
Amendment 23 #
Proposal for a regulation – amending act
Recital 7
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at CommunityEU level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk Assessment Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance auditCommittee.