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 Andrew'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.

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 Agencyâ??s Clinical Trials Unit.

Balall has a Bachelors in Pharmacology and a Masters in Computer Based Information Systems.

Maria Beatrice Panico is currently a Medical Assessor in the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA).

She is a medical doctor, fully qualified in Neurology with a PhD in Neuroscience. She has extensive experience in pharmacovigilance in the pharmaceutical industry.

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 a Lead Senior GCP Inspector 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.

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. Mulinde is currently the Senior Policy Advisor for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in CDER’s Office of New Drugs. She received her M.D. and completed a residency in Internal Medicine at the University of South Alabama School of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine. Before joining the FDA, she served as Assistant Professor of Medicine in the Division of Infectious Diseases, Program of Traumatology, at the University of Maryland’s R. Adams Cowley Shock Trauma Center.

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 Andrew'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.

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 Agencyâ??s Clinical Trials Unit.

Balall has a Bachelors in Pharmacology and a Masters in Computer Based Information Systems.

Maria Beatrice Panico is currently a Medical Assessor in the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA).

She is a medical doctor, fully qualified in Neurology with a PhD in Neuroscience. She has extensive experience in pharmacovigilance in the pharmaceutical industry.

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 a Lead Senior GCP Inspector 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.

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. Mulinde is currently the Senior Policy Advisor for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in CDER’s Office of New Drugs. She received her M.D. and completed a residency in Internal Medicine at the University of South Alabama School of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine. Before joining the FDA, she served as Assistant Professor of Medicine in the Division of Infectious Diseases, Program of Traumatology, at the University of Maryland’s R. Adams Cowley Shock Trauma Center.