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Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.


Faculty

  • Gaby L. Danan, MD, PhD

    Gaby L. Danan, MD, PhD

    • Pharmacovigilance Expert
    • GLD, France

    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.

  • Katherine  Donegan

    Katherine Donegan

    • Pharmacoepidemiology, Research & Intelligence Unit Manager
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and now manages the Pharmacoepidemiology research and Intelligence Unit. She has worked on a range of drug safety issues, including vaccines, with a recent focus on new approaches to proactive pharmacovigilance and monitoring outcomes and the effectiveness of risk minimisation measures using electronic healthcare record data.

  • 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.

  • Mick  Foy

    Mick Foy

    • Head of Pharmacovigilance Strategy
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team as since 2019 Head of PV Strategy. Amongst his responsibilities is to lead 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 and WHO. Mick continues to have oversight of the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is currently leading the MHRA’s transformation of vigilance systems with a remit to develop common IT and methodologies for medicines and devices. Mick is Chair of the MedDRA Management Committee, and a member of the Uppsala Monitoring Centre Board.

  • Claire  Longman

    Claire Longman

    • GPvP Inspector
    • MHRA, United Kingdom

  • Jan  Petracek

    Jan Petracek

    • Director
    • Institute of Pharmacovigilance, Czech Republic

    Dr. Jan Petracek has over 20 years of experience in all areas of pharmacovigilance. Between 2000-2010 he worked as a senior regulator, being former Head of Risk Management Section at EMA, Head of Pharmacovigilance and Head of Strategy and Development of the Czech NCA, and member of CHMP Pharmacovigilance Working Party. Between 2010-2020 he was CEO of multiple contract safety organisations, worked as contract EU QPPV for five MAHs, provided design of PV system and strategic advisory in relation to global PV system setups. His current main activity relates to development of International Society of Pharmacovigilance and its Special Interest Group on Career Framework for Pharmacovigilance Professionals.

  • Jonathan  Rowell

    Jonathan Rowell

    • Director Regulatory Compliance
    • Janssen Pharmaceutical Research & Development Quality & Compliance, United Kingdom

  • Phil  Tregunno

    Phil Tregunno

    • Group Manager, Vigilance, Intelligence and Research Group
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Phil is the Group Manager of the MHRA's Vigilance Intelligence and Research Group (VIRG) and has over seventeen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. He is responsible for the operational delivery of the Vigilance, Intelligence and Research Group, including delivery of relevant aspects of the Agency’s digital transformation programme.

  • Sarah  Vaughan

    Sarah Vaughan

    • Pharmacovigilance Information Unit Systems Manager
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. The unit has responsibility for handling Adverse Drug Reaction (ADR) data, signal management processes and the detection & evaluation of safety signals for established medicines. Alongside this Sarah has been an MHRA representative on the MedDRA Points to Consider Group, and has worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is as a Systems Manager in the Vigilance, Intelligence and Research Group working specifically on pharmacovigilance IT projects.

  • Margaret Anne Walters

    Margaret Anne Walters

    • Deputy EU Qualified Person for Pharmacovigilance
    • Merck, Sharp & Dohme Ltd, United Kingdom

    With 10 years in research and >30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology and drug safety

  • Julie  Williams, PhD

    Julie Williams, PhD

    • Expert Assessor
    • MHRA, United Kingdom

    She has worked in pharmacovigilance for almost 17 years having the joined the then Medicines Control Agency in 1998. Following realignment and formation of the MHRA she became a Unit Manager within the Risk Management Group and held that role until September 2013. She has been actively involved in providing expert advice to the UK representative at the Council Working Group influencing the UK’s position at the negotiations on the EU Pharmacovigilance legislation and more recently involved in work on transposition of the EU Directive into national legislation. Since September 2012 she has been the UK delegate of the EU PRAC and been actively involved in the work of the committee.

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