Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

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.

Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

Dr. Enrica Alteri is a Doctor in Medicine and Surgery from the University of Rome “La Sapienza” and holds post graduate qualifications from the National Cancer Institute USA and EUCOR/ECPM. Dr. Alteri has many years of experience from within the pharmaceutical Industry, specifically in the areas of drug discovery, clinical safety and pharmacovigilance. Dr. Alteri joined the European Medicines Agency as Head of Safety and Efficacy on 02 July 2012, which was followed by her appointment as Head of Human Medicines Evaluation Division in August 2013. On 01 September 2016 Enrica was appointed Head of Human Medicines Research & Development Support Division.

In her position as Head of Service E, Irene is responsible for ensuring the quality and consistency of PRAC recommendations, CHMP opinions and CMDh positions and their respective assessment reports for PSURs, PSUSAs and PASS procedures. In addition, the service provides regulatory and procedural support on these procedures to the network, as well as external stakeholders. Irene is also the EMA business lead of the PSUR repository project.

Anne Ambrose is an Expert Pharmaceutical Assessor and Specialist in Post Authorisation Operations and Safety Issues in the Vigilance and Risk Management of Medicines (VRMM) Division, MHRA, UK. She is a qualified pharmacist and has worked in hospital and retail pharmacy and the pharmaceutical industry. She worked for a number of years in Regulatory Affairs in the pharmaceutical industry before joining the Medicines Control Agency (now MHRA) in January 1995 as a pharmaceutical assessor. Anne was a UK expert to CMDh 2005-2020 and was involved in various CMDh working groups and was chair of the CMDh Working Party on Pharmacovigilance Procedures Worksharing (formerly EU PSUR Work Sharing Group) 2010-2017.

Jolanta Gulbinovic is currently the Chief Expert, Head of the Unit for Cooperation with the EMA and International Relations and Professor at Dept. of Pathology, Forensic medicine and Pharmacology at the Vilnius University. She received the MD in paediatrics at Vilnius University and did the PhD on drug utilization in Lithuania. Furthermore, she had a training in Clinical Pharmacology at Karolinska Institute in Stockholm. After that she worked as a Clinical Pharmacologist at Vilnius university hospital for more than ten years and as a Clinical Assessor at the Swedish Medicines Control Agency for more than three years. Recently she has been elected to the executive board of the European association of clinical pharmacology and therapeutics.

Klaudija is a physician with more than 20 years of experience in different pharmacovigilance fields. At present, she is Head of TPC – unit responsible for Company Core Safety Information, aggregate reports and risk management worldwide, supporting marketing authorizations and safety strategy for generics, biosimilar and innovative Teva products. Klaudija led in-house development of additional risk minimisation (ARM) implementation tracking tool and ARM digitalisation. Klaudija is Co-Chair of the Pharmacovigilance Working Group in Medicines for Europe.

Now a retired pharmacovigilance expert, Dr Auclert trained in clinical pharmacology and pharmaco-epidemiology after obtaining his MD in Paris. He started his career in the pharmaceutical industry in 1985, working in clinical development (clinical trials phase I to IV) for three companies (SK&F, Rhone-Poulenc, Hoechst-Roussel). In 1995, he moved into pharmacovigilance, joining AstraZeneca where he started as head of the French pharmacovigilance unit. From 2010 until his retirement in 2014, he was the QPPV of the Sanofi group. He chaired the EFPIA pharmacovigilance committee from 2012 to 2014.

Kristiina Puusaari is an eSubmission coordinator at the European Medicines Agency (EMA) working on Programme and Project Management for electronic submission systems and projects, such as eCTD, EMA eSubmission Gateway, electronic Application Form (eAF), Common Repository, PSUR Repository and the Single Submission Portal. Kristiina is the business domain expert for the EMA eSubmission systems as well as the Chair of the eSubmission Change Management Board. Kristiina also represents EMA in the ICH M8 IGW/EGW.

Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009 and joined PRAC at its establishment in 2012. As a member of EMA’s GPAG (Granularity and Periodicity Advisory Group) and SMART WG (Signal Management Review Technical working group) and of CMDh’s PhV WSP WP (Pharmacovigilance Worksharing Procedures Working Party), he has a special interest in PSURs and PSUSAs, signal detection and management, and Risk Management Planning.

Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana has been Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA, and is currently the Head of the Clinical Trials Transformation workstream at EMA.