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.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads 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.

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

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.

She has worked in pharmacovigilance for almost 17 years having the joined the then Medicines Control Agency in 1998. Following realignment and formation of the MHRA she became a Unit Manager within the Risk Management Group and held that role until September 2013. She has been actively involved in providing expert advice to the UK representative at the Council Working Group influencing the UK’s position at the negotiations on the EU Pharmacovigilance legislation and more recently involved in work on transposition of the EU Directive into national legislation. Since September 2012 she has been the UK delegate of the EU PRAC and been actively involved in the work of the committee.

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.

Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and having now been there over 13 years, Katherine leads their epidemiology team working closely with partners across the Agency to advise on the value of observational studies and to develop strategy on the use of real world data to support regulation. She has particulalr interests in the use of RWE to support pharmacovigilance, vaccines safety, and the role of observational data in evaluating the safety of medical devices.

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.

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.