With his team, he is responsible for overseeing i) the data collection, management and analysis activities related to the EudraVigilance system to support signal detection activities, ii) the EudraVigilance quality assurance framework and iii) all the processes related to the Medical Literature Monitoring (MLM).

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Main roles and responsibilities are within the signal management activities in the EMA Pharmacovigilance Office; to conduct of ad-hoc queries and related data analyses based on requests from (Co)-Rapporteurs, EMA’s Scientific Committees and relevant Working Parties in the context of product related safety issues using EVDAS; to provide expert advice to EMA product teams on pharmacovigilance/signal detection and management issues; to support the implementation of the EV Access Policy and address requests related to access to information/documents from EV; to support the implementation of the Pharmacovigilance legislation. Rodrigo is co-chair of the EudraVigilance Expert Working Group.

Qualified pharmacist with master in pharmaceutics and PhD in clinical pharmacology. Worked in pharmaceutical industry from 1998 until 2006 when he joined EMA in London. Currently Signal Management Lead for centrally authorised medicinal products within EMA Pharmacovigilance Office. Provides support in analysis and evaluation of EudraVigilance data. Assists the PRAC, Pharmacovigilance Business Team and EudraVigilance Expert Working Group on aspects related to safety reporting in pre- and post-marketing. Rapporteur of the Good Pharmacovigilance Practices (GVP) Module VI. Co-chair of the Pharmacovigilance Business Team. EU representative in ICH E19 and ICH E2D(R1) Expert Working Groups.

Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

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.

Tom Paternoster-Howe joined the EMA in 2004, where he has worked ever since. His work at the EMA has focused on the quality and analysis of data in Eudravigilance and he is currently the lead scientific administrator for both the Medical Literature Monitoring service & the Eudravigilance data management contract. Prior to joining the Agency, he worked for 3 years in the industry & at the MHRA in pharmacovigilance.

Loris Piccolo joined the EMA in 2013, and he has since worked on the management and analysis of EudraVigilance data to support pharmacovigilance activities. He is currently overseeing the maintenance and further development of the EVDAS system.

Michelle is leading the International Pharmacovigilance organization at MSD. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining MSD in 2002 she has performed various roles within PV including an EUQPPV support function, as well as prior regional operations roles in Asia Pacific and EMEA. Michelle has accountability for PV activities ex-US which consists of approx. 205 markets managed from 56 locations across the globe. Michelle is a part of the Global Clinical Safety and Pharmacovigilance Leadership Team, and works closely with HQ colleagues in the US. She is based in Europe.

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and have had several specialist, oversight and line managerial roles within the AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Eugène van Puijenbroek is a MD & clinical pharmacologist working since 1994 at the NL PV Centre Lareb. In 2001 he obtained a PhD degree at the Dpt. of Pharmacotherapy & Pharmacoepidemiology at the Utrecht Institute for Pharmaceutical Sciences. Since April 2014, he is professor of pharmacovigilance at the Faculty of Science and Engineering, Dpt. of PharmacoTherapy, -Epidemiology and -Economics of the University of Groningen. He obtained a vast experience analysing signals in the Dutch spontaneous reporting system and published in national & international journals. His current focus is on the development of signal detection methodologies, especially the integration of the statistical approach combined with the use of clinical information.

Katharina Weber, qualified pharmacist with master in pharmaceutics, worked several years in pharmaceutical industry before she joined the Austrian Agency for Health and Food Safety in 2007. Her activities in the field of pharmacovigilance include i) the coordination of the individual case reporting and signal detection group and ii) performing pharmacovigilance inspections. She is the national contact person for the Eudravigilance database and responsible for the training of new staff and the maintenance of the national PV database. In 2016 she completed training as an inspector in the field of pharmacovigilance. Since then, she has performed over 70 PV-inspections and is currently the member of the PV Inspectors working group.

Veronica Lipucci Di Paola joined the EMA in 2014, where she has worked ever since covering various roles. She holds a Master in Regulatory Affairs from TOPRA & University of Hertfordshire, a pharmacy degree and more than 10 years of data management experience in the field of Medicines for human use (area of pharmacovigilance and regulatory affairs). She is responsible to deliver the Product Management Services (PMS) and implementing ISO standards in Europe. She is a nominated EDQM Standard Terms Working Party’s expert, supporting other EMA Master Data Management Services on Substances, Products, Organisation and Referential data (known as SPOR). Prior joining the Agency, she worked as consultant and in the regional hospital center.

Luis Pinheiro, PharmD, MEpi, is responsible for developing and running real-world data analytics studies and is tasked with methods development and learning within the team. Luis is also a co-chair of the AI Technical Group at EMA. Before moving to the Data Analytics Workstream, he worked 8 years in drug safety. Prior to joining the EMA, he was the Head of the Signal Detection Unit at Infarmed and the Portuguese representative at the PV Working Party at EMA. Before that, he worked in the PV Unit of the Faculty of Pharmacy of Lisbon for 8 years where he assisted in the teaching of Pharmacoepidemiology and Public health in undergraduate and postgraduate courses.

Marcos Fernandez Gomez has a biotechnology degree and a Master in Biotechnology applied to the Pharmaceutical Industry. He worked in the past for a consultancy company focused on eSubmissions (eCTD and XEVMPD submissions), then he joined EMA in 2020 and he has been working since then as the PMS (Product Management Services) Product Owner and the XEVMPD Business Lead. Being one of the responsible persons in these two areas gives him an overview of the processes to manage product data and how it is used by the different stakeholders.