Andrew joined the MHRA in January 2003 as a GLP inspector. In 2004 Andrew was appointed as an inspectorate Operations Manager and in May 2006 took on the additional role of Heads of the United Kingdom Good Laboratory Monitoring Authority (GLPMA). Andrew is currently the Inspectorate Unit manager for the GLP/GCP/Pv teams.

In Andrews’s capacity as Head of the UK GLPMA he is a member of the OECD, EC & EMA GLP working groups and has contributed to a number of national and international guidance documents. Andrew has been involved in the training of GLP inspectors from monitoring authorities around the world and regularly speaks at international conferences on the maintenance of GLP compliance. Andrew was the Chair of the OECD GLP Working Group from 2014-2016. Andrew has also played a leading role in the development of the MHRA’s GCP laboratory inspection programme and was one of the authors of the current EMA Reflection Paper for laboratories that perform the analysis or evaluation of clinical trial samples.

Prior to joining the MHRA, Andrew worked in both academia and the pharmaceutical industry where he was primarily involved in the early development of drugs designed to treat cardiovascular disease. During this time Andrew regularly published peer reviewed papers in the scientific press.

Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management.

Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.

Gail holds a BSc (hons) in Applied Biology and a certificate in Human Pharmacology.

Jennifer joined the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector with promotion to senior GCP Inspector in 2010. Jennifer has a BSc in Chemistry and prior to joining the MHRA, spent 13 years in the Pharmaceutical industry. She started out in the pre-clinical analytical laboratory working to Good Laboratory Practice (GLP), then moved into Clinical Research and has held positions as a monitor, Clinical Research Associate (CRA)/Lead CRA and Project Manager in both the Pharmaceutical and Contract Research Organisation (CRO) environment. This has encompassed all types of clinical trials from Phase I/healthy volunteer trials through to Phase IV and has included a range of therapeutics areas, including oncology, wound management/burns, anaesthetics, urology, endocrinology and IMP devices.

Jennifer is currently acting as GCP Operations Manager and is responsible for the GCP inspection schedule and oversight of the MHRA voluntary Phase I Accreditation Scheme, and GCP forum. Jennifer was also one of the key contributors to the GCP guide published in 2012.

Hayley joined the MHRA in August 2015 as a GCP Inspector. Prior to joining the MHRA Hayley had worked in GCP Quality Assurance and Quality Systems since 2008 within commercial early phase clinical research organisations. Hayley has a BSc Hons in Pharmacology from the University of Manchester.

Lisa Campbell joined the MHRA in 2013, having worked in the NHS as a Clinician since 2001. Lisa’s medical specialty is in obstetrics and gynaecology. She has performed research whilst working within the NHS, and completed an MD in high risk obstetrics, and been an investigator in a number of clinical trials.

Lisa is a Medical Assessor in the Clinical Trials Unit and has assessed over 1,000 clinical drug trial applications. As a medical assessor, she is also involved in giving scientific advice to drug developers on their clinical development programmes, including how a clinical trial should be designed and the regulatory routes to market.

Emma Whale is a Senior GCP and GLP Inspector for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in July 2008, Emma worked for eight years as a GLP Auditor and Deputy GLP Quality Manager with experience in both Sponsor Organisations and Contract Research Organisations. Emma has also worked in histopathology for a large agrochemical company and she has an honours degree in Biomedical Sciences.

In her role at the Agency, Emma conducts GCP inspections of both commercial and non-commercial organisations, phase 1 accreditation inspections, clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies.

Mandeep initially joined the MHRA as a Good Clinical Practice (GCP) Inspector in October 2008. She has since taken up the post of GPvP (Good Pharmacovigilance Practice) Operations Manager and is cross-training as a Pharmacovigilance Inspector. Prior to joining the MHRA, Mandeep worked for the pharmaceutical industry, the MHRA and the NHS. Mandeep has a BSc (Hons) in Pharmacology from King’s College London and is studying for an MSc in Public Health. Mandeep is also the current chair of the PIC/S GCP & GPvP Working Group.

Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group, and a Senior GCP and GLP Inspector for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also worked in the manufacturing sector and is a Chartered Chemist and Chartered Quality Professional.

In his role as an inspector, Stephen conducts GCP and GLP inspections of commercial organisations and laboratories in the UK, in addition to inspection of overseas facilities as part of the MHRA inspection programme for organisations conducting bioequivalence studies.

Michael joined the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2015 as a GLP & GCP Inspector within the laboratories inspection team. Prior to joining Michael worked for 5 years in a Quality Assurance (QA) organisation, working with a range of organisations including GLP programme members who conducted a variety of test types and laboratories involved in the conduct of clinical trial sample analysis.

In his role at the Agency, Michael conducts clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies. Michael has a BSc Hons degree in Chemistry from the University of the West of Scotland.

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector and became a Senior Inspector in 2015 conducting a variety of inspections including GCP inspections of sponsors, CROs and laboratories, bioequivalence trials and GLP inspections. Jason has a split role between the GCP and laboratories inspection teams within the MHRA.

Jason has a BSc (hons) in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance (PTQA).

Previously Jason spent seven years in the NHS working in hospital pharmacy (including clinical trials and manufacturing).