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Pharmacovigilance Conference


Speakers

  • 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.

  • Maria  Wishart

    Maria Wishart

    • Medical Director, Global Patient Safety
    • Astrazeneca, United Kingdom

    Maria qualified in Medicine from Cambridge University and became an Anaesthetist, working in the UK National Health Service. Her early industry career included roles in phase I clinical trials and in PET imaging as part of the GlaxoSmithKline Translational Medicine team. In 2004 joined the Global Clinical Safety & PV department, working in the neurosciences area and managing a team providing clinical safety for a portfolio of investigational & marketed products. In 2012, she became Deputy EU QPPV and in 2016 she joined AstraZeneca as Deputy EU QPPV. In 2019 Maria moved roles into therapy area-aligned clinical safety. She is now responsible for clinical-strategic leadership for assigned products in the oncology area.

  • 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

    • Senior Vice Preseident and Group Strategic Head
    • APCER Life sciences, United States

  • Peter Richard Arlett, MD, FFPM, FRCP

    Peter Richard Arlett, MD, FFPM, FRCP

    • Head Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Dr Peter Arlett - Head, Data Analytics and Methods Task Force, 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) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; 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, MD

    Francoise Dumas-Sillan, MD

    • EU & UK QPPV, VP Global Patient Safety
    • Ipsen, France

    Françoise is a medical doctor as background, working in Pharmacovigilance for more than 30 years in big Pharmaceutical companies with different managerial roles, interactions with Health Authorities, and coordination of international networks 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. Within the EFPIA Pharmacovigilance expert group, she analysed the influence of EU pharmacovigilance regulations outside Europe and of non EU regulations on the EUQPPV role.

  • Mick  Foy

    Mick Foy

    • Group Manager, Vigilance Intelligence and Research Group
    • 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.

  • 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, MSc

    Anna Adams, PhD, MSc

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

    Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016. Since then, she has inspected the pharmacovigilance systems of all types of pharmaceutical organisations from large innovator firms, to small biotech start-ups, to international organisations with established generic portfolios, and everything in between. Her career in pharmacovigilance started with processing Yellow Card reports at the MHRA in 2007 before she completed a PhD in peptide chemistry with molecular biology at University College London. Anna then returned to work in the field of pharmacovigilance at a large pharmaceutical company, before she re-joined the MHRA as an Inspector and received promotion to Senior Inspector in 2019.

  • Marin  Banovac

    Marin Banovac

    • Scientific Officer
    • European Medicines Agency, Netherlands

    Marin Banovac is a pharmacist with an MSc in Clinical Pharmacology. After initial work experience in pharmaceutical industry, he worked for the Croatian Medicines Agency as a pharmacovigilance assessor and afterwards as an alternate member in Pharmacovigilance Risk Assessment Committee (PRAC). He was a seconded national expert at the EMA in Pharmacovigilance Department – Signal Management, later to join EMA as a Risk Management Specialist in Oncology, Haematology and Diagnostics Office. He is the coordinator of EMA Risk Management Community, and a lecturer in pharmacovigilance at Zagreb Faculty of Pharmacy.

  • Sabine  Brosch, PharmD, PhD, MPharm

    Sabine Brosch, PharmD, PhD, MPharm

    • Principal Scientific Administrator, Surveillance and Epidemiology
    • European Medicines Agency, Netherlands

    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
    • 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

    • EU QPPV Head QPPV Office
    • 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

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

    Rory has over 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

    • EMA Liaison Official to FDA
    • European Medicines Agency, Netherlands

    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
    • 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 Pharmacovigilance and Risk Management
    • Seqirus UK Limited, 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, Qualified Person for Pharmacovigilance
    • Bristol-Myers Squibb, United Kingdom

    Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.

  • Nuria  Semis-Costa, MSc

    Nuria Semis-Costa, MSc

    • Scientific Officer
    • European Medicines Agency, Netherlands

    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, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.

  • Sabine  Straus, MD, PhD, MSc

    Sabine Straus, MD, PhD, MSc

    • PRAC Chair, Staff 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

    • Associate Director, Office of the EU QPPV
    • Merck Sharp & Dohme Limited, United Kingdom

    Dionne Usher works in the Office of the EU QPPV and is based at MSD in the UK. Primary responsibilities are managing the Company’s EudraVigilance Access, Steward for the Company’s Pharmacovigilance System Master File and other ad hoc EU QPPV Office projects and activities.

  • Magnus  Ysander, MD

    Magnus Ysander, MD

    • EU QPPV & Head Pharmacovigilance Excellence
    • AstraZeneca, 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. A long-term member of DIA, previously contributed to training workshops for new QPPVs as well as functioned as session lead and presenter at the DIA QPPV Forum.

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

    • 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.