Regulatory Affairs Consultant, DI REES Ltd
Ian joined the MHRA as a GMP inspector in 2001, before this he was an inspector with the Veterinary Medicines Directorate and before that worked for a startup biopharmaceutical firm during which time it was authorised by US FDA and MCA (later, MHRA). In 2004, Ian became a manager responsible for the London based team of GMP inspectors, he was promoted to Expert GMP Inspector in 2006 and Unit Manager Inspectorate Strategy and Innovation in 2014 managing a team of Expert Inspectors. Between 2008 and 2015, Ian was MHRA’s representative on the EMA’s GMDP Inspectors Working Group during this time he also chaired the EMA/HMA’s Joint Audit Programme which is responsible for equivalence of EEA GMP inspectorates, development of best practice standards, meeting standards in Mutual Recognition Agreements and those in the PIC/S Joint Reassessment Programme. Ian was also one of the MHRA’s representative at EU Blood Authority Meetings. Ian was part of the MHRA’s Innovation Office team and UK cross regulatory ‘One Stop Shop’ providing regulatory advice and guidance to organisations developing innovative processes or novel manufacturing processes. In the restructured MHRA, a Science Research and Innovation Group was created which incorporated the Innovation Office, Ian became an assessor in this Group. Ian led MHRA’s work in developing the new regulatory framework for distributed and point of care manufacture until he retired from MHRA in March 2023.