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Pharmacovigilance Conference


Speakers

  • 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, Inspectorate, Enforcement and Standards
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Jo joined the MHRA Inspectorate in 2007, having worked for 15 years in the pharma industry. Throughout 2010-2012, she led the inspectors' contribution to the Implementing Regulation and specific statutory guidance GVP Modules in support of the pharmacovigilance legislation changes. She has experience in implementing the new requirements within Industry, returning to MHRA in 2015, within the Inspectorate Strategy & Innovation Unit.

  • Reena  Harjai, MD

    Reena Harjai, MD

    • Director, Pharmacovigilance
    • APCER Life Sciences, United States

  • Peter  Arlett, MD, FRCP

    Peter Arlett, MD, FRCP

    • Head of Pharmacovigilance and Epidemiology Department
    • European Medicines Agency, United Kingdom

    Dr Peter Arlett - Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Harvard Business School: Certificate Management Course 2017 Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – present; Honorary Clinical Senior Lecturer, Barts and the London School of Medicine, 2016 – present; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996

  • 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.

  • Francoise  Dumas-Sillan

    Francoise 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
    • MHRA, United Kingdom

    Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates Foundation funded project to build PV capacity in low and middle income countries and the IMI funded WEB-RADR project to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

  • 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

  • Anna  Adams, PhD

    Anna Adams, PhD

    • GPvP Inspector, Inspection, Enforcement & Standards
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Anna joined the MHRA as a PV Inspector at the start of 2016 having previously worked as a PV Scientist in industry. In her previous work she was involved in many aspects of PV operations and her experience includes end-to-end handling of ICSRs; identifying and implementing process improvements; and the quality management system. Prior to this, Anna completed a PhD in Chemistry with Molecular Biology at University College London as part of the Wellcome Trust Interdisciplinary PhD programme. During Anna’s undergraduate Masters’ degree in Chemistry, she had multiple placements, both in industry, and at the MHRA in the Vigilance and Risk Management of Medicines (VRMM) division, where she started her career in pharmacovigilance.

  • Marin  Banovac

    Marin Banovac

    • Scientific Officer
    • 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

    Ermishina Olga is the Pharmacovigilance Country Head, EAEU Qualified Person for Pharmacovigilance in Bayer company. She graduated from Russian State Medical University, biophysics course. Olga is in pharmaceutical business since 1997, being involved in product promotion, medical support, non-interventional studies and interventional clinical trials. For the last 13 years she is in pharmacovigilance.

  • Charlotte  Goldsmith

    Charlotte Goldsmith

    • Signal Management Coordinator, Vigilance Intelligence and Research Group
    • MHRA, United Kingdom

  • Vineet  Kacker, PhD

    Vineet Kacker, PhD

    • Managing Director and Global Technical Head
    • APCER Life Sciences, United Kingdom

    Dr. Kacker is a Pharmacologist by training, having completed his PhD in Pharmacology from All India Institute of Medical Sciences in India. Dr. Kacker switched his interests from academia to pharmaceutical industry more than 18 years ago, and has managed the Regulatory and Pharmacovigilance functions at global organizations. Dr. Kacker is a co-founder of APCER Life Sciences, having started the company out of UK more than 11 years ago. In his current role he operates as the Managing Director and Global Technical Head of APCER. Dr. Kacker has been a Qualified Person/Person Responsible for Pharmacovigilance with experience of more than 17 years as EU-QPPV and in his current role he does operate as the EU-QPPV for some of APCER’s clients.

  • David John Lewis, PhD

    David John Lewis, PhD

    • Global Head of Pharmacovigilance, Senior Visiting Fellow, Univ. of Hertfordshire
    • Novartis Pharma AG, Switzerland

    Dr Dave Lewis is Global Head of Pharmacovigilance at Novartis Pharma AG. He was previously in drug safety at GSK & legacy companies & at Shire. He is Visiting Senior Fellow, Faculty of Health and Human Sciences, University of Hertfordshire and assists the DSRU in an honorary advisory capacity.

  • Rory  Littlebury

    Rory Littlebury

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

    Rory has ten years experience working at the MHRA, including working within Licensing and Pharmacovigilance Divisions prior to taking on a Pharmacovigilance Inspector role. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national pharma companies to healthcare professionals and patients, giving a well-rounded view of the difficulties and challenges faced by those in, or affected by, the regulations of pharmaceuticals in the UK and within the EU.

  • Anabela  Marcal, PharmD

    Anabela Marcal, PharmD

    • Head of Committees 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.

  • Elspeth  McIntosh

    Elspeth McIntosh

    • Director
    • Castle Pharmacovigilance Ltd, United Kingdom

    Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and works as a contract QPPV for small companies and provides general PV support to a wide range of pharma companies.

  • 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.

  • Michael  Richardson, MD, FFPM

    Michael Richardson, MD, FFPM

    • International GPV&E and EU QPPV
    • Bristol-Myers Squibb, United Kingdom

    Currently International Head of BMS’s Pharmacovigilance Function and EU QPPV based in the UK. He is medically qualified graduating from Stellenbosch University and specialised in Obstetrics and Gynaecology. He practiced in Cambridge prior to joining the Pharmaceutical industry in Clinical Research and then Medical affairs. He has worked in major MNCs across the globe and heading up Research and Development in Asia. He is also a long serving member of the EFPIA PV committee, served on ICH E2C(R2) EWG and Q&A IWG. Additionally Heads BMS Global Risk Management function.

  • Nuria  Semis-Costa, MSc

    Nuria Semis-Costa, MSc

    • Scientific Officer
    • 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 works in the Office of the EU QPPV and is based at MSD in the UK. Originally part of the team that developed the Company’s PSMF and has been in the PSMF Steward role since then; taking care of the end-to-end project management and production. Also currently working as part of a team aiming to develop pragmatic approaches to meeting growing requirements as we move towards PSMF globalisation When she’s not doing the PSMF she’s supporting other EU QPPV Office projects and activities.

  • 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 moved to AstraZeneca in 2000 as head of Safety & Medical Information at the UK affiliate 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.