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.

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

Main roles and responsibilities are with the implementation of the EudraVigilance database and international standardisation development through involvement with ICH, ISO and HL7. This also involves providing technical and practical advice to Marketing Authorisation Holders, National Competent Authorities and Sponsors of Clinical Trials on how to implement IT systems to submit data on Adverse Drug Reaction reports electronically to the EudraVigilance database.

Florence van Hunsel (1981) studied Pharmaceutical Sciences at the University of Utrecht in the Netherlands from 1999-2005. She has been working at the Netherlands Pharmacovigilance Centre Lareb since 2005 where she is currently Head of Signal Detection. Florence wrote her PhD thesis on ‘The contribution of direct patient reporting to pharmacovigilance’ (University of Groningen, 2011). She is still actively involved in studies on patient reporting in pharmacovigilance and has supervised multiple PhD projects on this topic.

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.