Andrew joined the MHRA in January 2003 as a GLP inspector. In 2004 Andrew was appointed Operations Manager for the Good Laboratory Practise and Good Distribution Practise Groups. In May 2006 Andrew took on the role of Heads of the United Kingdom Good Laboratory Monitoring Authority. Most recently in September 2014 Andrew was appointed Inspectorate Unit manager.

In Andrews’s capacity as Head 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 is currently the Chair of the OECD GLP Working Group.

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.

Stephen is Operations Manager for the GLPMA and Laboratories Group 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.

Lesley has been working as a leading Senior Inspector with the MHRA for the past 14 years. During this time she has conducted inspections across several for the GXPs namely GLP, GCP and GMP of contract labs and IMPs sites. As well as being part of the UK Good Laboratory Practice Monitoring Authority, Lesley was also responsible for setting up the routine programme of inspections of UK GMP contract laboratories.

Lesley spent the very early years of her career working in the quality contract labs at Boots, then in a research lab at Strathclyde University. After graduating in 1994 as an analytical chemist she joined the pharmaceutical industry. Working initially as an analyst in the quality control laboratory then as a supervisor within manufacturing, here she was responsible for the manufacture of simple solutions and suspensions used in pre-clinical studies, to the more complex formulated products used in clinical trials through to scale up and production of large phase III, comparator and commercial products. It was during her time in the pharmaceutical industry Lesley first gained experienced of working to both GLP and GMP.

Lynsay joined the agency in October 2016 as a GLP Inspector within the laboratories inspection team.

Her previous experience includes over 12 years in industry working in stability analysis, formulation analysis, several quality assurance roles, and latterly as a Regulatory Consultant. She also spent some time in the oil industry working with scale inhibitors.

Lynsay completed her honours degree in Biochemistry at the University of Stirling in 2005.

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. 

Martin joined the agency in June 2015 as a GLP Inspector within the laboratories inspection team having worked for 7 years in contract research organisations. During these 7 years he built up experience of working in GLP compliant facilities as well as conducting clinical trial sample analysis.

He has a Batchelor's degree in Biochemistry from the University of Newcastle.

Jason joined the MHRA in November 2006 as a GCP Inspector and became a leading 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).

Chris Gray is an Operations Manager within GMP and a senior inspector. Having joined MHRA in 2007 as a GLP inspector she was cross-trained to inspect laboratories working to GMP and took up a management role within the GMP Inspectorate in October 2014. In addition to managing a team of inspectors, Chris continues to conduct inspections of laboratories working to both GLP and GMP.

Prior to joining the agency Chris held a variety of positions in her 13 years in industry including working as a GLP Study Director in 2 large UK CROs, and 6.5 years working as an analytical chemist within DEFRA.

After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996.

My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological.  A further aspect of my job is to offer regulatory advice to companies on behalf of  the MHRA or the EU’s Committee for Human Medicinal Products (CHMP).  I am one of the UK’s accredited non-clinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP).  I represented the EU in the ICH revision of the M3 Guideline and on the new ICH S10 Guideline.

I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics).

I work closely with the NC3Rs and represent the MHRA on a Governmental body dealing with animal welfare.

I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.

Andrew joined the MHRA in January 2003 as a GLP inspector. In 2004 Andrew was appointed Operations Manager for the Good Laboratory Practise and Good Distribution Practise Groups. In May 2006 Andrew took on the role of Heads of the United Kingdom Good Laboratory Monitoring Authority. Most recently in September 2014 Andrew was appointed Inspectorate Unit manager.

In Andrews’s capacity as Head 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 is currently the Chair of the OECD GLP Working Group.

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.

Stephen is Operations Manager for the GLPMA and Laboratories Group 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.

Lesley has been working as a leading Senior Inspector with the MHRA for the past 14 years. During this time she has conducted inspections across several for the GXPs namely GLP, GCP and GMP of contract labs and IMPs sites. As well as being part of the UK Good Laboratory Practice Monitoring Authority, Lesley was also responsible for setting up the routine programme of inspections of UK GMP contract laboratories.

Lesley spent the very early years of her career working in the quality contract labs at Boots, then in a research lab at Strathclyde University. After graduating in 1994 as an analytical chemist she joined the pharmaceutical industry. Working initially as an analyst in the quality control laboratory then as a supervisor within manufacturing, here she was responsible for the manufacture of simple solutions and suspensions used in pre-clinical studies, to the more complex formulated products used in clinical trials through to scale up and production of large phase III, comparator and commercial products. It was during her time in the pharmaceutical industry Lesley first gained experienced of working to both GLP and GMP.

Lynsay joined the agency in October 2016 as a GLP Inspector within the laboratories inspection team.

Her previous experience includes over 12 years in industry working in stability analysis, formulation analysis, several quality assurance roles, and latterly as a Regulatory Consultant. She also spent some time in the oil industry working with scale inhibitors.

Lynsay completed her honours degree in Biochemistry at the University of Stirling in 2005.

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. 

Martin joined the agency in June 2015 as a GLP Inspector within the laboratories inspection team having worked for 7 years in contract research organisations. During these 7 years he built up experience of working in GLP compliant facilities as well as conducting clinical trial sample analysis.

He has a Batchelor's degree in Biochemistry from the University of Newcastle.

Jason joined the MHRA in November 2006 as a GCP Inspector and became a leading 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).

Chris Gray is an Operations Manager within GMP and a senior inspector. Having joined MHRA in 2007 as a GLP inspector she was cross-trained to inspect laboratories working to GMP and took up a management role within the GMP Inspectorate in October 2014. In addition to managing a team of inspectors, Chris continues to conduct inspections of laboratories working to both GLP and GMP.

Prior to joining the agency Chris held a variety of positions in her 13 years in industry including working as a GLP Study Director in 2 large UK CROs, and 6.5 years working as an analytical chemist within DEFRA.

After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996.

My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological.  A further aspect of my job is to offer regulatory advice to companies on behalf of  the MHRA or the EU’s Committee for Human Medicinal Products (CHMP).  I am one of the UK’s accredited non-clinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP).  I represented the EU in the ICH revision of the M3 Guideline and on the new ICH S10 Guideline.

I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics).

I work closely with the NC3Rs and represent the MHRA on a Governmental body dealing with animal welfare.

I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.