Jason 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).

Jennifer joined the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector with promotion to senior GCP Inspector in 2010 and Lead Senior GCP Inspector in Aug 2017. 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 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 has acted as GCP Operations Manager during Paula Walkers maternity leave 2016-2017, she is responsible for the GCP inspection programme and was also one of the key contributors to the GCP guide published in 2012.

Gail 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.

Mandy joined the MHRA in April 2014 as a GCP Inspector and conducts GCP Inspections. Prior to joining the MHRA, Mandy spent seven years working in the pharmaceutical industry in a variety of clinical roles. Mandy started her career as a Clinical Research Associate and has experience of working in Quality Assurance and Audit. Mandy has an MSc in Toxicology and a BSc (Hons) in Medical Biochemistry.

Paula Walker currently works for the MHRA as a Good Clinical Practice (GCP) Inspectorate Operations Manager and a Senior GCP inspector, having worked for the Agency since April 2009. Paula has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. Prior to joining the Agency Paula worked in research governance and clinical trials regulation in the non-commercial sector. She started in the NHS working in research and development in a number of roles including ethics management and training, and subsequently worked as a research manager in the higher education sector. Following this she moved back into clinical research and trials regulation working in a number of universities and charity organisations, providing operational and regulatory support for sponsored trials. Paula has been a GCP inspector for the MHRA since 2009 and an Inspectorate Operations Manager for the past 5 years, with responsibility for the GCP Inspectorate team.

Dr Lisa Campbell joined the MHRA in July 2013 as a Medical Assessor in the Clinical Trial Unit at the MHRA.  Lisa has a vast experience of assessing clinical trial applications, having assessed around 1300 in total, at a National and European level and has joined the GCP Inspectors on a number of occasions at triggered inspections.

Lisa has a BSc degree in Biology in addition to her Medical Degree.  Lisa trained as an Obstetrician and Gynaecologist and worked in the NHS for 12 years. She also has spent time in research and has an MD in ‘Diabetes in Pregnancy’.

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 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.

Andy has a BSc (Hons) in Biology and a MSc in Medical Statistics and IT. Andy worked as a Medical Statistician after gaining his MSc, being involved primarily in clinical trial design and data analysis. He also undertook some data management activities. After 3 years in this role, he moved into clinical research and became a Clinical Research Associate (CRA) at the start of 1996 and progressed to be a Clinical Project Manager. During these 7 years Andy was involved in a broad range of clinical trial activities for trials of pharmaceuticals and medical devices. He also had a part time role during his time as a CRA as an ISO9001 internal auditor. Andy’s last 2 years in industry prior to joining the MHRA were spent as Compliance and Training Manager within clinical research. Andy has been with the MHRA GCP Inspectorate since August 2005 and has inspected numerous commercial and non-commercial organisations, contract research organisations, phase 1 clinical units and investigator sites as part of the MHRA and EMA inspections. He also worked with EU GCP inspector colleagues in the EMA GCP Inspectors Working Group sub-groups on Quality Risk Management, TMFs and Source Data that were responsible for the respective EU reflection papers.

Jason 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).

Jennifer joined the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector with promotion to senior GCP Inspector in 2010 and Lead Senior GCP Inspector in Aug 2017. 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 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 has acted as GCP Operations Manager during Paula Walkers maternity leave 2016-2017, she is responsible for the GCP inspection programme and was also one of the key contributors to the GCP guide published in 2012.

Gail 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.

Mandy joined the MHRA in April 2014 as a GCP Inspector and conducts GCP Inspections. Prior to joining the MHRA, Mandy spent seven years working in the pharmaceutical industry in a variety of clinical roles. Mandy started her career as a Clinical Research Associate and has experience of working in Quality Assurance and Audit. Mandy has an MSc in Toxicology and a BSc (Hons) in Medical Biochemistry.

Paula Walker currently works for the MHRA as a Good Clinical Practice (GCP) Inspectorate Operations Manager and a Senior GCP inspector, having worked for the Agency since April 2009. Paula has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. Prior to joining the Agency Paula worked in research governance and clinical trials regulation in the non-commercial sector. She started in the NHS working in research and development in a number of roles including ethics management and training, and subsequently worked as a research manager in the higher education sector. Following this she moved back into clinical research and trials regulation working in a number of universities and charity organisations, providing operational and regulatory support for sponsored trials. Paula has been a GCP inspector for the MHRA since 2009 and an Inspectorate Operations Manager for the past 5 years, with responsibility for the GCP Inspectorate team.

Dr Lisa Campbell joined the MHRA in July 2013 as a Medical Assessor in the Clinical Trial Unit at the MHRA.  Lisa has a vast experience of assessing clinical trial applications, having assessed around 1300 in total, at a National and European level and has joined the GCP Inspectors on a number of occasions at triggered inspections.

Lisa has a BSc degree in Biology in addition to her Medical Degree.  Lisa trained as an Obstetrician and Gynaecologist and worked in the NHS for 12 years. She also has spent time in research and has an MD in ‘Diabetes in Pregnancy’.

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 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.

Andy has a BSc (Hons) in Biology and a MSc in Medical Statistics and IT. Andy worked as a Medical Statistician after gaining his MSc, being involved primarily in clinical trial design and data analysis. He also undertook some data management activities. After 3 years in this role, he moved into clinical research and became a Clinical Research Associate (CRA) at the start of 1996 and progressed to be a Clinical Project Manager. During these 7 years Andy was involved in a broad range of clinical trial activities for trials of pharmaceuticals and medical devices. He also had a part time role during his time as a CRA as an ISO9001 internal auditor. Andy’s last 2 years in industry prior to joining the MHRA were spent as Compliance and Training Manager within clinical research. Andy has been with the MHRA GCP Inspectorate since August 2005 and has inspected numerous commercial and non-commercial organisations, contract research organisations, phase 1 clinical units and investigator sites as part of the MHRA and EMA inspections. He also worked with EU GCP inspector colleagues in the EMA GCP Inspectors Working Group sub-groups on Quality Risk Management, TMFs and Source Data that were responsible for the respective EU reflection papers.