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.

Jo Harper is MHRA’s Expert Inspector in Pharmacovigilance, with 6 years of inspection experience. Throughout 2010-2012, she led the MHRA inspectors and EU PV Inspector’s Working Group contribution to the development of the Implementing Regulation and GVP Modules in support of the pharmacovigilance legislation changes. Jo also has extensive pharmaceutical Industry experience, most recently enjoying the challenges of implementing the new requirements before returning to MHRA in 2015, within the Inspectorate Strategy & Innovation Unit.

Mandeep Rai initially joined the MHRA as a Good Clinical Practice (GCP) Inspector in October 2008. In 2013, Mandeep took up the post of Pharmacovigilance Inspectorate Operations Manager and began cross-training as a Pharmacovigilance Inspector.

Mandeep is also the current chair of the PIC/S GCP & GPvP Working Group and is responsible for managing the global joint visit programme for GCP and Pharmacovigilance: https://picscheme.org/en/activites-expert-circles-working-group-on-good-clinical-and-good-pharmacovigilance-practices

Prior to joining the MHRA, Mandeep worked for the pharmaceutical industry, the MHRA and the National Health Service. Mandeep has a BSc (Hons) in Pharmacology from King’s College London and is studying for an MSc in Public Health at the London School of Hygiene and Tropical Medicine.

Claire joined the MHRA as a Pharmacovigilance Inspector in July 2014. Prior to joining the Agency, Claire held various positions within the Pharmaceutical Industry including those of Pharmacovigilance Scientist, UK Local Safety Officer and Medical Information Scientist.   Her experience covers an extensive number of pharmacovigilance processes including handling of ICSRs from receipt to submission (post marketing and clinical trials), signal detection practices and PSUR authoring. In addition, Claire has worked in Consultancy with a primary focus in Risk Management activities. Claire has a BSc in Human Biology from Loughborough University and a MSc in Health Sciences.

Mark joined the MHRA in 2002 and is currently the Group Manager for the Inspectorate which comprises of over 80 Inspectors. Mark is a chemistry graduate with an MSc in pharmaceutical sciences. He previously worked in the pharmaceutical industry for over 10 years in a variety of roles including process technology, new product introduction and quality assurance and he is eligible to be named as a Qualified Person under Directive 2001/83/EC.

Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016 having previously worked as a Pharmacovigilance Scientist in industry.  In her previous work she was involved in many aspects of pharmacovigilance operations and her experience includes end-to-end handling of ICSRs (post marketing and clinical trials); identifying and implementing process improvements; and the quality management system, with involvement in the oversight of training, supporting audits, and the management of deviations and CAPA.  Prior to this, Anna completed a PhD in Chemistry with Molecular Biology at University College London as part of the Wellcome Trust Interdisciplinary PhD programme.  During Anna’s undergraduate Masters’ degree in Chemistry, she had multiple placements, both in industry, and at the MHRA in the Vigilance and Risk Management of Medicines (VRMM) division, where she started her career in pharmacovigilance.

Rory has extensive experience of the regulators environment, having nine years experience working at the MHRA. He has worked in various roles within the MHRA’s Licensing division and Vigilance and Risk Management of Medicines (VRMM) division before moving into an inspector role within the Inspectorate, Enforcement and Standards division. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national pharma companies to healthcare professionals and patients, giving a well-rounded view of the difficulties and challenges faced by those in, or affected by, the regulations of pharmaceuticals in the UK and within the EU.

Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012.  She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP) and has had a role in the training of GPvP Inspectors in other EU Member States.

Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials.

Kiernan has a Master of Biomedical Sciences degree from the University of Southampton and a Post-graduate Certificate in Pharmacovigilance.

Catharine joined the Inspectorate in 2010 and has experience as a GDP, GCP and Pharmacovigilance Inspector. Prior to this, she worked as a Scientific Assessor in the MHRA’s Licensing Division. Before joining the MHRA, Catharine gained valuable experience in pharmacovigilance in the pharmaceutical industry and as a quality manager and project manager for a regulatory consultancy.

Sophie joined the GPvP Inspectorate in January 2018 after having worked as scientific assessor of safety variations in the Product Information Quality Unit at the MHRA. Previously, she had worked for a Medical Information service provider covering a large portfolio of medicines and medical devices. Sophie started her career in the pharmaceutical sector at a company in Germany where she was jointly responsible for the compilation of the non-clinical summary in the CTD for a sedative drug. Sophie has an MSc in Forensic Anthropology and a degree in Human Biology.

Phil is Interim Group Manager of the MHRA's Vigilance Intelligence and Research Group (VIRG) and has over fourteen years of experience working in pharmacovigilance. Prior to his current role Phil spent over nine years leading and developing the Signal Management function within the MHRA, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. Phil also led the development and delivery of the IMI WEB-RADR Project and remains active in ensuring the impact of its outputs are optimised.

Shahin graduated from Liverpool John Moores University with a BSc Hons in Pharmaceutical and Chemical Sciences and has passed the Certificate in Pharmacoepidemiology & Pharmacovigilance at the London School of Hygiene and Tropical Medicine.

Shahin is a lead senior scientific assessor and joined the Medicines and Healthcare products regulatory (MHRA) Agency (former MCA) in 2001. She has extensive experienced of the ‘life-cycle’ of pharmacovigilance both nationally and at EU level that includes ADR report processing, signal detection, assessment and prioritisation, benefit-risk assessments and post-authorisation safety studies. Her current portfolio includes monitoring the post-marketing safety of medicines in the therapeutic areas:

• blood disorders (i.e. granulocyte colony stimulating factors and epoetins)
• multiple myeloma (i.e. histone deacetylase inhibitors)
• malignant melanoma (i.e. immune check point inhibitors)
• myelofibrosis (i.e. protein kinase inhibitors).

Shahin has expertise in assessing risk management plans, additional risk minimisation measures and assessing their effectiveness on a European and national level.

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.

Jo Harper is MHRA’s Expert Inspector in Pharmacovigilance, with 6 years of inspection experience. Throughout 2010-2012, she led the MHRA inspectors and EU PV Inspector’s Working Group contribution to the development of the Implementing Regulation and GVP Modules in support of the pharmacovigilance legislation changes. Jo also has extensive pharmaceutical Industry experience, most recently enjoying the challenges of implementing the new requirements before returning to MHRA in 2015, within the Inspectorate Strategy & Innovation Unit.

Mandeep Rai initially joined the MHRA as a Good Clinical Practice (GCP) Inspector in October 2008. In 2013, Mandeep took up the post of Pharmacovigilance Inspectorate Operations Manager and began cross-training as a Pharmacovigilance Inspector.

Mandeep is also the current chair of the PIC/S GCP & GPvP Working Group and is responsible for managing the global joint visit programme for GCP and Pharmacovigilance: https://picscheme.org/en/activites-expert-circles-working-group-on-good-clinical-and-good-pharmacovigilance-practices

Prior to joining the MHRA, Mandeep worked for the pharmaceutical industry, the MHRA and the National Health Service. Mandeep has a BSc (Hons) in Pharmacology from King’s College London and is studying for an MSc in Public Health at the London School of Hygiene and Tropical Medicine.

Claire joined the MHRA as a Pharmacovigilance Inspector in July 2014. Prior to joining the Agency, Claire held various positions within the Pharmaceutical Industry including those of Pharmacovigilance Scientist, UK Local Safety Officer and Medical Information Scientist.   Her experience covers an extensive number of pharmacovigilance processes including handling of ICSRs from receipt to submission (post marketing and clinical trials), signal detection practices and PSUR authoring. In addition, Claire has worked in Consultancy with a primary focus in Risk Management activities. Claire has a BSc in Human Biology from Loughborough University and a MSc in Health Sciences.

Mark joined the MHRA in 2002 and is currently the Group Manager for the Inspectorate which comprises of over 80 Inspectors. Mark is a chemistry graduate with an MSc in pharmaceutical sciences. He previously worked in the pharmaceutical industry for over 10 years in a variety of roles including process technology, new product introduction and quality assurance and he is eligible to be named as a Qualified Person under Directive 2001/83/EC.

Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016 having previously worked as a Pharmacovigilance Scientist in industry.  In her previous work she was involved in many aspects of pharmacovigilance operations and her experience includes end-to-end handling of ICSRs (post marketing and clinical trials); identifying and implementing process improvements; and the quality management system, with involvement in the oversight of training, supporting audits, and the management of deviations and CAPA.  Prior to this, Anna completed a PhD in Chemistry with Molecular Biology at University College London as part of the Wellcome Trust Interdisciplinary PhD programme.  During Anna’s undergraduate Masters’ degree in Chemistry, she had multiple placements, both in industry, and at the MHRA in the Vigilance and Risk Management of Medicines (VRMM) division, where she started her career in pharmacovigilance.

Rory has extensive experience of the regulators environment, having nine years experience working at the MHRA. He has worked in various roles within the MHRA’s Licensing division and Vigilance and Risk Management of Medicines (VRMM) division before moving into an inspector role within the Inspectorate, Enforcement and Standards division. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national pharma companies to healthcare professionals and patients, giving a well-rounded view of the difficulties and challenges faced by those in, or affected by, the regulations of pharmaceuticals in the UK and within the EU.

Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012.  She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP) and has had a role in the training of GPvP Inspectors in other EU Member States.

Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials.

Kiernan has a Master of Biomedical Sciences degree from the University of Southampton and a Post-graduate Certificate in Pharmacovigilance.

Catharine joined the Inspectorate in 2010 and has experience as a GDP, GCP and Pharmacovigilance Inspector. Prior to this, she worked as a Scientific Assessor in the MHRA’s Licensing Division. Before joining the MHRA, Catharine gained valuable experience in pharmacovigilance in the pharmaceutical industry and as a quality manager and project manager for a regulatory consultancy.

Sophie joined the GPvP Inspectorate in January 2018 after having worked as scientific assessor of safety variations in the Product Information Quality Unit at the MHRA. Previously, she had worked for a Medical Information service provider covering a large portfolio of medicines and medical devices. Sophie started her career in the pharmaceutical sector at a company in Germany where she was jointly responsible for the compilation of the non-clinical summary in the CTD for a sedative drug. Sophie has an MSc in Forensic Anthropology and a degree in Human Biology.

Phil is Interim Group Manager of the MHRA's Vigilance Intelligence and Research Group (VIRG) and has over fourteen years of experience working in pharmacovigilance. Prior to his current role Phil spent over nine years leading and developing the Signal Management function within the MHRA, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. Phil also led the development and delivery of the IMI WEB-RADR Project and remains active in ensuring the impact of its outputs are optimised.

Shahin graduated from Liverpool John Moores University with a BSc Hons in Pharmaceutical and Chemical Sciences and has passed the Certificate in Pharmacoepidemiology & Pharmacovigilance at the London School of Hygiene and Tropical Medicine.

Shahin is a lead senior scientific assessor and joined the Medicines and Healthcare products regulatory (MHRA) Agency (former MCA) in 2001. She has extensive experienced of the ‘life-cycle’ of pharmacovigilance both nationally and at EU level that includes ADR report processing, signal detection, assessment and prioritisation, benefit-risk assessments and post-authorisation safety studies. Her current portfolio includes monitoring the post-marketing safety of medicines in the therapeutic areas:

• blood disorders (i.e. granulocyte colony stimulating factors and epoetins)
• multiple myeloma (i.e. histone deacetylase inhibitors)
• malignant melanoma (i.e. immune check point inhibitors)
• myelofibrosis (i.e. protein kinase inhibitors).

Shahin has expertise in assessing risk management plans, additional risk minimisation measures and assessing their effectiveness on a European and national level.