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).

Balall joined the Inspections Enforcement and Standards (IE&S) division of the MHRA in June 2014 as a GCP Inspector and conducts GCP Inspections. Balall has been at the MHRA since May 2005 and has worked in a variety of roles across our Vigilance and Risk Management in Medicines (VRMM) and Licensing Divisions. Prior to starting his current roles he was working as a Senior Clinical Safety Scientists within the Agency’s Clinical Trials Unit. Balall has a Bachelors in Pharmacology and a Masters in Computer Based Information Systems.

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.

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).

Balall joined the Inspections Enforcement and Standards (IE&S) division of the MHRA in June 2014 as a GCP Inspector and conducts GCP Inspections. Balall has been at the MHRA since May 2005 and has worked in a variety of roles across our Vigilance and Risk Management in Medicines (VRMM) and Licensing Divisions. Prior to starting his current roles he was working as a Senior Clinical Safety Scientists within the Agency’s Clinical Trials Unit. Balall has a Bachelors in Pharmacology and a Masters in Computer Based Information Systems.

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.