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Pharmacovigilance Conference


  • Gaby L. Danan, DIAFellow, MD, PhD

    Gaby L. Danan, DIAFellow, MD, PhD

    • Pharmacovigilance Expert
    • France

    Gaby L. Danan is board qualified in Hepatology and Internal Medicine. He conducted experimental and clinical studies dealing with drug hepatotoxicity and drug-drug interactions. He joined the pharmaceutical industry in 1984 and was EU QPPV in Sanofi S.A. before his retirement in 2010. Together with Dr Christian Benichou he published in 1993 a causality assessment method for suspected Drug-Induced Liver Injury known as RUCAM. From 1992 to 2009, he was a member of several CIOMS groups and ICH Expert Working Groups especially on Clinical Safety as EFPIA topic leader of E2B. He co-chaired with the EMA the EV Expert Working Group from its creation to 2009. He authored numerous papers and book chapters on definitions and methodology in PV.

  • Maria  Wishart

    Maria Wishart

    • Deputy EU QPPV
    • Astrazeneca, United Kingdom

    Her early industry career was in phase I clinical trials with GlaxoSmithKline. Staying with the same company, Maria moved into Experimental Medicine and worked in the field of PET Imaging in early drug discovery for several years, before taking a position in Global Clinical Safety and Pharmacovigilance in 2004 as a Safety Physician. Maria worked in the neurosciences area and soon moved into a Therapy Area Director role in Safety. In 2012, Maria became Deputy EU QPPV at GlaxoSmithKline and took on management of the QPPV Office as well as development of the Pharmacovigilance System Master File. In 2016, Maria joined AstraZeneca as Deputy EU QPPV.

  • Joanna  Harper

    Joanna Harper

    • Expert Inspector, GPvP
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    I started with the MHRA in 2007, having spent 15 years in the pharma industry. Throughout 2010-2012, I led the inspectors contribution the Implementing Regulation and specific GVP Modules in support of the pharmacovigilance legislation changes. Recently, I was implementing the new requirements within Industry, before returning to MHRA in 2015, within the Inspectorate Strategy & Innovation Unit.

  • Reena  Harjai, MD

    Reena Harjai, MD

    • Director, Clinical Safety and Pharmacovigilance
    • APCER Life Sciences, United States

  • 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.

  • Françoise  Dumas-Sillan

    Françoise Dumas-Sillan

    • EU QPPV
    • Pfizer Italia SRL., Italy

    Françoise is a medical doctor as background, working in Pharmacovigilance for more than 20 years in big Pharmaceutical companies with different managerial roles (Sanofi, now Pfizer), exposure to international activities and interactions with Health Authorities, and has been in charge of the coordination of the international network of Pharmacovigilance. She has spent 15 Years on Vaccine Pharmacovigilance where she contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. She analysed the influence of EU pharmacovigilance regulations outside Europe and the impact of these new non-European regulations on the EUQPPV office She is a member of Pharmacovigilance Expert Group at EFPIA

  • Mick  Foy

    Mick Foy

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

    Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 9 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible for two large European projects to improve drug safety monitoring. The EC funded SCOPE (Strengthening Collaborations to Operate Pharmacovigilance in Europe) Joint Action aims to improve the pharmacovigilance capabilities of national regulators in Europe, and the Innovative Medicines Initiative funded WEB-RADR (Recognising Adverse Drug Reactions) project seeks to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

  • Margaret Anne Walters

    Margaret Anne Walters

    • Director & 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

  • Marin  Banovac

    Marin Banovac

    • European Medicines Agency, United Kingdom

  • Sabine  Brosch, PharmD, PhD, MPharm

    Sabine Brosch, PharmD, PhD, MPharm

    • Principal Scientific Administrator, Surveillance and Epidemiology
    • European Medicines Agency, European Union, United Kingdom

    Sabine Brosch joined the EMA in 1996 and served as Deputy Head of Sector for Pharmacovigilance, Post-Authorisation Safety and Efficacy of Medicines at the EMA until 2009. In 2010 she took up her role as Business Lead in EudraVigilance and International Standardisation in Pharmacovigilance. In December 2013, she joined the new Monitoring and Incident Management Services of the Pharmacovigilance Department as Principal Scientific Administrator.

  • Olga  Ermishina

    Olga Ermishina

    • Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU
    • Bayer, Russian Federation

  • Charlotte  Goldsmith

    Charlotte Goldsmith

    • Associate Signal Assessor
    • MHRA, United Kingdom

  • Representative Invited

    Representative Invited

    • Teva Pharmaceuticals Europe B.V.
  • Representative Invited

    Representative Invited

    • APCER Life Sciences
  • Representative Invited

    Representative Invited

    • Novartis Pharma AG
  • Anabela  Marcal, PharmD

    Anabela Marcal, PharmD

    • Head of Compliance and Inspections Department
    • European Medicines Agency (EMA), United Kingdom

    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.

  • James  Milligan

    James Milligan

    • Vice President Patient Safety
    • AstraZeneca, United Kingdom

    Joined Industry more than 10 years ago after training in hospital medicine and neuro-immunology research in the UK. Interests from clinical practice include cardiology, neurology and rheumatology. Experience covering pharmacovigilance at all stages of lifecycle as well as multiple successful NDA and MAA submissions across major therapy areas. Currently leads a global group of Safety Physicians and Scientists across US and Sweden and covering therapy areas of Respiratory, Inflammation, Autoimmunity, Infection and Vaccines. James is actively involved promoting scientific thinking from basic sciences through to challenges of public health and real-world risk management.

  • Nuria  Semis-Costa, MSc

    Nuria Semis-Costa, MSc

    • European Medicines Agency (EMA), United Kingdom

    Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology and immunology. Núria is also involved in initiatives related to biosimilars, pregnancy or the update of the RMP template and provides scientific assistance to the Blood Products Working Party.

  • Sabine  Straus, MD, PhD, MSc

    Sabine Straus, MD, PhD, MSc

    • Head of Pharmacovigilance. PRAC member
    • Medicines Evaluation Board (MEB), Netherlands

    Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

  • Dionne  Usher

    Dionne Usher

    • Senior Specialist, EU QPPV Office
    • MSD Ltd, United Kingdom

    Dionne joined MSD’s Regulatory Affairs Department in 1989 and moved into PV in 1994 where one of her first tasks was to help establish the Office of the EU QPPV. Based in the UK, much of her current role is taken up managing the PV System Master File (PSMF), supporting the various PSMF-related requests (ie for PV inspections) and EudraVigilance.

  • Magnus  Ysander, MD

    Magnus Ysander, MD

    • EU QPPV & Head Pharmacovigilance Excellence
    • AstraZeneca AB, Sweden

    Magnus Ysander is the EU QPPV for AstraZeneca since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and has had several specialist, project lead and line managerial roles within the AstraZeneca pharmacovigilance organisation. This has lead to experience from both development and marketed medicinal products, small molecules as well as biologics. Trained as an Orthopedic Surgeon, Magnus has worked as a clinician at a county hospital and has also been engaged in an innovation medical device company, developing bone anchored prostheses for lower limb amputees. Magnus is a long-term member of DIA and has previously contributed to training sessions for new QPPVs, providing input from a large pharma perspective.

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

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

    Vicki Edwards qualified as a pharmacist and spent time in hospital pharmacy and community pharmacy before going GlaxoWellcome in 1995 to begin her career in pharmacovigilance – she began life as a case processor. She moved to AstraZeneca in 2000 as head of Safety and Medical Iformation at the UK marketing company and moved to Abbott as QPPV in 2005. When Abbott split into Abbott and AbbVie in 2013 Vicki became AbbVie QPPV and Head of Affiliate Vigilance Excellence. Today Vicki is Vice President, Pharmacovigilance Excellence and QPPV.