Robert Bream

Since 2012, Robert Bream has worked as a quality specialist in the Pharmaceutical Quality Office at the European Medicines Agency. His role involves peer review of quality aspects of new and generic medicinal products from development phase (scientific advice), through initial authorisation (MAA) to life cycle management (variations, line extensions) and the drafting of the associated assessment reports. He also supports the development of scientific guidelines by the Quality Working Party (QWP), Biologics Working Party (BWP) and the EMA PAT Team and is a member of the EDQM CEP Steering Committee. He was deputy EU topic lead in the ICH Q11 Q&As Expert Working Group (EWG) from 2014 to 2017 and has been deputy EU topic lead in the ICH Q2/Q14 EWG since 2018.

Before joining the EMA, Robert spent 7 years in the pharmaceutical industry as a chemistry project leader, development chemist and as a medicinal chemist supporting various clinical programmes, which was preceded by 2 years’ post-doctoral research at Stanford University.

He holds an M.Sci. in Natural Sciences and a Ph.D. in synthetic organic chemistry, both from the University of Cambridge.

Before joining the EMA, Robert spent 7 years in the pharmaceutical industry as a chemistry project leader, development chemist and as a medicinal chemist supporting various clinical programmes, which was proceeded by 2 years’ post-doctoral research at Stanford University.

He holds an M.Sci. in Natural Sciences and a Ph.D. in synthetic organic chemistry, both from the University of Cambridge.