Senior Pharmaceutical Quality Specialist
European Medicines Agency, Netherlands
Robert Bream joined the EMA in 2012 and is a senior pharmaceutical quality specialist in the Pharmaceutical Quality Office. 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, quality defects, referrals) and the drafting of the associated assessment reports. He also supports the development of scientific guidance by the EMA’s working parties (QWP and BWP) and is a member of the EDQM CEP Steering Committee. He also has extensive experience of drafting ICH guidance, including ICH Q1, Q2, Q14 and M7 on mutagenic impurities. On behalf of the EMA, Robert has been leading on quality aspects of nitrosamine impurities 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’ postdoctoral research in organometallic catalysis 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.
Recent Developments in Nitrosamines
Thursday, October 9, 2025
3:15 PM - 4:15 PM EST