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EMA EudraVigilance & Signal Management Virtual Information Day

This virtual live Information Day will focus on the ISO 27953-2:2011 as well as ISO 11239:2012 standards which will become applicable as of 30 June 2022 for all reporting to EudraVigilance. It will also highlight the impact on EV and Signal Management with regard to COVID-19 and provides an update on the revision of the existing ICH-E2D.


  • Paolo  Alcini

    Paolo Alcini

    • Head of Healthcare Data
    • European Medicines Agency, Netherlands

    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).

  • Georgy  Genov, MD

    Georgy Genov, MD

    • Head of Pharmacovigilance Office, Quality and Safety of Medicines Department
    • European Medicines Agency, Netherlands

    Dr Georgy Genov is qualified as medical practitioner. He joined the pharmaceutical industry in 1998. Since then he has gained experience in Drug Development, Medical Affairs and Pharmacovigilance. In 2010, he joined the Pharmacovigilance and Risk Management team of the European Medicines Agency. At the beginning of 2020 he assumed the role of Head of Signal and Incident Management Office. In 2011 Dr Genov was appointed Head of Pharmacovigilance Office, which provides leadership and coordination across the pharmacovigilance activities of the Agency, including coordinating the EMA pharmacovigilance matrix and the EU-level activities across the Member States.

  • Rodrigo  Postigo

    Rodrigo Postigo

    • Scientific Administrator
    • European Medicines Agency, Netherlands

    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.

  • Gilles  Touraille, PharmD, PhD

    Gilles Touraille, PharmD, PhD

    • Scientific Administrator
    • European Medicines Agency, Netherlands

    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, MSc

    Anja Van Haren, MSc

    • EudraVigilance Coordinator
    • Medicines Evaluation Board (MEB), Netherlands

    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.

  • Vicki  Edwards

    Vicki Edwards

    • Vice President, Pharmacovigilance Excellence and International QPPV
    • AbbVie, Inc., United Kingdom

    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.

  • Karin  Gamba

    Karin Gamba

    • Senior Project Manager, Training
    • DIA, Switzerland

  • Nick  Halsey

    Nick Halsey

    • Scientific Administrator
    • European Medicines Agency, Netherlands

    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, PharmD, PhD

    Florence van Hunsel, PharmD, PhD

    • Head Signal Detection
    • Netherlands Pharmacovigilance Centre Lareb, Netherlands

    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

    Tom Paternoster-Howe

    • Scientific Administrator, Data Analytics and Methods
    • Task Force - Healthcare Data, European Medicines Agency, Netherlands

    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.

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