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.

Sabine Brosch was appointed DPO at EMA in January 2022. She joined EMA in 1996 and has been working in pharmacovigilance, clinical trials and international harmonisation (ICH) and standardisation (ISO) focusing on the development of the Individual Case Safety Report and Identification of Medicinal Products standards as well as the medical terminology MedDRA. She holds a master’s degree in pharmacy and a doctor of natural sciences degree of the University of Vienna, Austria.

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.

Dr. Harrison is the Chief Medical Officer of the MedDRA Maintenance and Support Services Organization (MSSO) where she is responsible for overall medical strategy. She has over 25 years’ experience in clinical research and pharmacovigilance, and is a member of the ICH M1 “Points to Consider” Working Group and the CIOMS Implementation Working Group on Standardised MedDRA Queries (SMQs).

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.

Oversees the maintenance and development of MedDRA for over 3600 international organizations.

Coordinator for Project team for implementation of pharmacovigilance legislation, secretariat for EudraVigilance Expert Working Group (EV-EWG), Contribution to the co-ordination and elaboration of policies, detailed business requirements and guidance in line with the EV-EWG Work Programme. MedDRA liaison for MSSO/ICH M1 PTC on aspects of coding of ICSRs, EMA co-rapporteur for deliverables in medication error action plan related to coding and reporting, Package 1 co-lead IMI WEBRADR Project.

Dr Winter has over 20 years’ experience in pharmacovigilance and clinical terminologies. She provided medical advice for the company specific terminology (pre-MedDRA) and participated in the working groups that created MedDRA. She is an European Federation of Pharmaceutical Industries Associations (EFPIA) representative in the MedDRA Management Board, the ICH MedDRA Points to Consider working group. She is also a member of the CIOMS Standardised MedDRA Queries working group. Prior to joining the pharmaceutical industry, she was a clinical lecturer in the University of Leeds (UK) where she gained experience as an investigator in clinical trials.