Brian Dooley has worked as a quality specialist in the Specialised Scientific Disciplines Department of EMA since 2016.
His role involves performing scientific peer review of assessments in new centralised marketing authorisation applications, line extensions, variations, scientific advice procedures, and supporting the development of scientific guidelines by the Committee for Medicinal Products for Human Use (CHMP), its Quality Working Party (QWP), Biological Working Party (BWP), and other working parties and committees of EMA as necessary. He has supported the ICH Q12 drafting process since 2016 and is the EMA member of the Q12 Expert Working Group since mid-2018.
From 2008 to 2016, Brian worked as a pharmaceutical assessor in the IMB/HPRA (Ireland), where he assessed marketing authorisation, clinical trial and scientific advice applications and managed teams working on post-authorisation variations, renewals, parallel imports and herbal medicines. From February 2015 to January 2016, he was the Irish member of the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human).
Brian’s main areas of interest within quality assessment are post-authorisation lifecycle management, assessment-inspection interface, synthetic peptides, oligonucleotides and sterile products. He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) from Trinity College Dublin, Ireland.