Ian Rees

Assessor at MHRA

Speaker

Ian joined the MHRA as a GMP inspector in 2001, before this he was an inspector with the Veterinary Medicines Directorate and before that he helped create a startup biopharmaceutical firm during which time it was authorised by US FDA and MHRA’s predecessor, the MCA. 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 GXP Inspectors. Between 2008 and 2015, Ian was MHRA’s representative on the EMA’s GMDP Inspectors Working Group and also chaired the EMA/HMA Joint Audit Programme. Ian was also one of the MHRA’s representative at EU Blood Authority Meetings.

Ian was part of the team that created MHRA’s Innovation Office in 2013 to provide regulatory advice to organisations developing innovative processes or novel manufacturing processes. In 2014 Ian was part of the team that created the UK cross regulatory ‘One Stop Shop’ to provide regulatory advice on ATMPs. Based on enquiries received by MHRA, Ian led MHRA’s work in developing the new regulatory framework for decentralised manufacture. Although he retired from MHRA in March 2023 he has since rejoined MHRA on a part-time basis to help complete the development of this new regulatory framework. On January 23rd 2025 the legislation (SI 2025 87) was signed into UK law and guidance documents were published on 10 June ahead of the legislation coming into 23rd July 2025.