Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
Ian is the Manager for the Inspectorate Strategy and Innovation Unit. This unit leads the development of the Inspectorate strategy across all GXP disciplines linking Agency and Government priorities to the work of the Group.
Before becoming an inspector, Ian worked for a start up biopharmaceutical firm for 14 years and is a veterinary surgeon by original qualification. Ian was a GMP inspector with the Veterinary Medicines Directorate for 2 years prior to joining MHRA in 2001. In 2004 Ian became an Operations Manager with responsibility for the team of GMP inspectors based in London. In 2006 he was promoted to his current role. Ian now has a focus on biological/biotechnology products and blood components. Ian is the MHRA’s representative on the EMA’s GMP/GDP Inspectors Working Group, this group has as its key responsibility the development and maintenance of GMP and GDP.
Ian was the rapporteur for the 2013 revision of Annex 2 of EU GMP, which gives guidance on the manufacture of human biological medicinal products which includes ATMPs. Ian is also heavily involved in the MHRA's Innovation Office and the UK cross-Agency (HTA, HRA, HFEA and MHRA) Regenerative Medicine Regulatory Advice Service to provide a ‘one stop shop’ (OSS) service for this new sector.
MHRA has now published 7 case studies highlighting the work of our Innovation Office and showing how we help organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to effectively navigate regulatory processes, so they can progress their products …