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.

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.

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.

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation and policy development in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision of ICH GCP E6 (revision 3). He previously held inspection and management positions at the Irish Health Products Regulatory Authority (HPRA) and UK-MHRA, and positions in pharmacovigilance, medical affairs and good distribution practice in industry. He holds a BSc and Masters degrees in pharmacy, and two Bachelor of Laws degrees.

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.

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.

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.