BPharm (Hons) PhD MRPharmS CSci CChem MRSC FTOPRA
EU Pharmaceutical Regulatory Consultant and Lecturer on ‘Quality’ Matters
A pharmaceutical consultant for 15 years based in the United Kingdom providing:
- Expert regulatory advice and insight on medicines licensing (gaining and maintaining Marketing Authorisations) and associated procedural and technical strategies
Key areas of activity are:
- Dossier preparation and gap analysis
- Active Substance Master Files (ASMFs)
- Certificate of Suitability (CEP) dossiers
- In-company / In-house staff training
- European pharmacopoeia / British pharmacopoeia
- Expert Witness statements on Chemistry, Manufacturing and Control (CMC) subjects
- Internal (in-company) and external (public) staff training on pharmaceutical regulatory legislation, guidelines and licensing / post-licensing policies for medicinal products in the EU to the chemical and pharmaceutical industries.
He is a Visiting Lecturer at King's College, University of London. He is a Quality Assessor on the WHO Prequalification Programme (Geneva – Copenhagen) and he also writes scientific papers on CMC subjects.
Previously, for almost 20 years, Mike worked at the Medicines Control Agency (MCA), now the Medicines and Healthcare products Regulatory Agency (MHRA) in London, first as a Pre-Clinical Assessor and then a Pharmaceutical Assessor. In the latter role he assessed many hundreds of Marketing Authorisation new applications (for New and Existing Drug Products), and tens of thousands of Variation applications.
Earlier, before becoming a regulatory assessor, Mike worked from 1969 to 1981 in the pharmaceutical industry gaining experience in Quality Control and Research & Development operations and became eligible to register as a Qualified Person.