Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016. Since then, she has inspected the pharmacovigilance systems of all types of pharmaceutical organisations from large innovator firms, to small biotech start-ups, to international organisations with established generic portfolios, and everything in between. Her career in pharmacovigilance started with processing Yellow Card reports at the MHRA in 2007 before she completed a PhD in peptide chemistry with molecular biology at University College London. Anna then returned to work in the field of pharmacovigilance at a large pharmaceutical company, before she re-joined the MHRA as an Inspector and received promotion to Senior Inspector in 2019.

Lu Larham has worked in pharmacovigilance for over 14 years and is a Director of Global Safety at Amgen Ltd. Lu is currently the business process owner for periodic aggregate safety reporting. She has also worked in safety surveillance, safety compliance and quality management. Prior to joining Amgen, Lu worked at the Medicines Control Agency and in the Global Clinical Safety and Pharmacovigilance group at GSK. Lu holds a BSc (Hons) in Pharmacology from the University of Bristol and a Post-Graduate Certificate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine.

Ms Marriott is leading/supporting and executing the Regulatory Authority Inspection strategies (communication, preparation, conduct & hosting, responding and follow-up) as well as supporting the development/optimization and executing the GXP mock inspection program. She is also leading/supporting Inspection management strategies & activities for critical GXP inspections.

Sophie have been working at the MHRA for over 4 years and is currently a team co-ordinator within the MHRA’s Vigilance Intelligence and Research Group (VIRG). Sophie’s team have responsibility for handling ADR data, signal detection and the evaluation of safety signals for established medicines and responding to PV enquiries. Alongside these responsibilities, Sophie has additional roles in the maintenance of the terminologies used by the unit including the MHRA Drugs Dictionary and MedDRA. She has also had important roles in the integration of electronic reporting into clinical IT systems in the UK.

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.