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Meeting Speakers from the Medicines and Healthcare products Regulatory Agency
We are honored to have the Medicines and Healthcare products Regulatory Agency partner so closely with us, especially at time where innovation has been catalyzed. Learn more below about these leaders of today.
Meet Our Confirmed Speaker from the Medicines and Healthcare products Regulatory Agency
David Brown, Unit Manager of the Statistics and Pharmacokinetics Unit
David Brown is the head of the Statistics team at the MHRA. He has over 20 years’ experience as a statistical assessor at the MHRA, and prior to Brexit was a member of both the biostatistics working party and scientific advice working party at the EMA. He was part of the group that formulated the recently published MHRA guidance on real-world data.
Mandy Budwal-Jagait, MSc, GPvP Operations Manager and Lead Senior GCP Inspector
Mandy Budwal-Jagait is a GPvP Operations Manager and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. Mandy conducts a variety of GCP inspections in commercial and non-commercial organisations, including Phase I units registered under the MHRA Phase I Accreditation Scheme.
Prior to joining the Agency, Mandy has held Clinical Research and Quality Assurance roles in the Pharmaceutical Industry. She holds a MSc in Toxicology and BSc (Hons) in Medical Biochemistry.
Mick Foy, Deputy Director of Patient Safety Monitoring
Mick Foy has been with the MHRA for more than 30 years; he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring. Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.
Mick continues to have responsibility for the UK Yellow Card scheme with regard to the vigilance of medicines, medical devices and blood. Mick is Chair of the MedDRA Management Committee.
Krishna Prasad, DrMed, MD, FRCP, Deputy Director, Innovative Medicines, HQA/Licensing
Krishna Prasad is a Group Manager at the UK Regulatory Agency with management responsibility for Cardiovascular- diabetes, anti-infective agents, oncology and musckuloskeletal therapy areas for the last 18 months. Dr Prasad’s additional roles include Cardiology consultancy at St. Thomas’ hospital, London. Dr Prasad qualified in 1987 obtaining his MD in 1989 and completing Certification in Cardiology subsequently in the UK. He has worked for MHRA, the UK regulatory agency since 2002 initially as reviewer progressing to lead the cardiology-diabetes areas and subsequently to the current post. Dr Prasad’s areas of special interest in cardiology include heart failure, sudden death, cardiomyopathies and arrhythmias.
Sophie Radicke, MSc, Pharmacovigilance Inspector, Inspectorate, Enforcement & Standards
Sophie has been a pharmacovigilance inspector at the MHRA since January 2018. Prior to joining the GPvP Inspectorate, she was responsible for the assessment of Type IB safety variations in the MHRA’s Vigilance and Risk Management of Medicines division for two years. Before joining the MHRA, Sophie worked in medical information where she also supported quality assurance activities and the accreditation of new staff.
Sophie started her career in the pharmaceutical sector when she worked on a regulatory affairs project for a mid-sized pharmaceutical company in Germany. Sophie has an MSc in Forensic Anthropology and a master’s degree in Human Biology during which she specialised in pharmacology, pathology, and virology.
Phil Tregunno, Head of Vigilance Operations, Safety & Surveillance
Phil is the Head of Vigilance Operations within the MHRA's Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. He is responsible for the operational delivery of the Vigilance, Intelligence and Research Group, including delivery of relevant aspects of the Agency’s digital transformation programme.
Sarah Vaughan, Head of Vigilance Development
Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. She has been MHRA representative on the MedDRA Points to Consider Group and worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is the Head of Vigilance Development, focusing on the development and transformation of the Agency's vigilance systems for all medicinal product types. Sarah leads on key projects in the Agency's Patient Safety function, engaging with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes.
Jason Wakelin-Smith, Lead Senior GCP and GLP Inspector, Healthcare Quality and Access
Jason joined the MHRA in November 2006 as a GCP Inspector, became a Senior Inspector in 2015 and a Lead Senior Inspector in August 2017. Jason has a split role between the GCP and laboratories inspection teams within the MHRA conducting a variety of inspections including GCP inspections of sponsors, CROs and analytical laboratories, bioequivalence trials and GLP inspections.
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 UK National Health Service working in hospital pharmacy (including clinical trials and manufacturing).
Paula Walker, MA, Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle)
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle. She has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. In 2020/21 Paula chaired the International Coalition of Medicines Regulatory Authorities (ICMRA) working group on Remote GCP & GMP inspections during the pandemic, resulting in the publication of an international reflection paper on changing approaches to inspections published at the end of 2021.
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