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.

Zuzana Chomatova is an inspector at the Pharmacovigilance department of the State Institute for Drug Control (SUKL) since 2011. Before taking this role, she worked as a Pharmacovigilance data manager at the SUKL. Since 2010 she is EMA Pharmacovigilance Inspectors Working Group member. She graduated University of Chemistry and Technology in Prague in 1993.

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.

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.

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

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.

Suzie is a senior pharmacoepidemiologist working in the MHRA's Benefit/Risk Management Group. She joined the MHRA in 2003 and has a specific interests in vaccines, medicines used in pregnancy and signal detection methodology. Suzie has responsibility for optimising methods for drug/vaccine safety signal detection at the MHRA, conducting observational research studies to support regulatory decision making and assessing post-authorisation safety studies.

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.