Michael is a Principal Consultant, acting as a CMC Subject Matter Expert who routinely helps clients with their product development, clinical trial applications (CTAs) and marketing authorisation applications (MAAs), as well as their interactions and meetings with regulators. Michael works with small and large molecules.
Prior to working at PAREXEL, Michael worked as Pharmaceutical Assessor/CMC-Reviewer at the UK’s MHRA for almost 6 years.
In this role he assessed a substantial number of MAAs under a variety of legal basis, involving multiple dosage forms and application procedures; as well as reviewing a considerable number of Clinical Trial Applications (CTAs).
Michael has provided scientific and regulatory advice to companies on behalf of the MHRA and the EMA and has authored communications on behalf of the UK Secretary of State for Health. He also played a role in the UK’s efforts in facilitating innovation in the UK Life Sciences industry, helping to set up and operate the MHRA’s Innovation Office and being a UK representative in the EU Innovation Network chaired by the EMA’s Innovation Task Force.
He is an expert in generic medicines, having assessed over a hundred generic MAAs at the MHRA and has also recently updated a chapter on generic medicines in the new edition of the Regulatory Affairs Professionals (RAPS) Fundamentals of EU Regulatory Affairs. Michael is also a CMC clinical trial application expert, having reviewed over a hundred UK CTAs and was part of an assessment team which reviewed urgent applications for treatments and vaccinations during the Ebola outbreak. Michael also has experience with US/global regulatory submissions, drug-device combinations, orphan drug designation and new chemical entity review.
He has also previously worked as an NHS clinical pharmacist.
Monday, September 23
2:05 PM – 3:00 PM