Brian Dooley has worked as a quality specialist in the Pharmaceutical Quality Office of EMA since 2016. His role involves performing scientific peer review of assessments in new centralized marketing authorization 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. Brian has been the EU deputy topic lead in the ICH 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 authorization, clinical trial and scientific advice applications and managed teams working on post-authorization 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 Decentralized Procedures – Human). Brian’s main areas of interest within quality assessment are post-authorization lifecycle management, assessment-inspection interface, synthetic peptides, oligonucleotides and sterile manufacture. He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) from Trinity College Dublin, Ireland.