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11th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 11th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants.


  • Peter  De Veene, MD

    Peter De Veene, MD

    • Head Global Drug Safety & QPPV
    • Grunenthal Gmbh, Germany

    Peter got his medical degree from the Catholic University of Leuven in Belgium and until the end of 2003, Peter practised as a General Practitioner in the UK. In 2004, he joined Roche as a drug safety physician in the local organisation. Taking up roles with increasing responsibility, Peter was appointed Qualified Person for Pharmacovigilance for Roche in 2011. He left Roche at the end of 2014 to take a role at Daichii Sankyo and moved on to be the Head of Global Drug Safety & QPPV for Grunenthal. Peter has extensive experience in pre-approval and post-marketing pharmacovigilance.

  • 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.

  • 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

  • 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.

  • Brian David Edwards, DrMed

    Brian David Edwards, DrMed

    • Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES
    • NDA Regulatory Science Ltd., United Kingdom

    After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, Treasurer of ISoP and Vice President in the Alliance Clinical Research Excellence and Safety (ACRES) .

  • Barbara  De Bernardi, MD

    Barbara De Bernardi, MD

    • Deputy EU QPPV and European Safety Office Head
    • Pfizer Italia S.r.l., Italy

  • 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.

  • Winrich  Rauschning, DrMed, MD, MBA

    Winrich Rauschning, DrMed, MD, MBA

    • QPPV
    • Biolitec Pharma, Germany

  • Doris Irene Stenver, MD, MPA

    Doris Irene Stenver, MD, MPA

    • Chief Medical Officer
    • Danish Medicines Agency, Denmark

    Doris Irene Stenver is the Danish delegate in the Pharmacovigilance Risk Assessment Committee. She joined the Danish Medicines Agency in 1998 and has more than 20 years of experience in the field of Pharmacovigilance. Prior to joining the Danish agency she worked as Hospital Physician and is specialized in internal medicine.

  • Representative Invited

    Representative Invited

    • MSD
  • Francois  Domergue

    Francois Domergue

    • EV Auditable Requirement Project Manager, Business Data and Analytics Department
    • European Medicines Agency, United Kingdom

    After studies in clinical research and development, specialising in Clinical data management, Francois worked for pharmaceutical companies in various position in clinical data management. He joined the European Medicines Agency in 2009 where he works in the Data Standardisation and Analytics service of Information Management Division. He is the project manager of the EudraVigilance Auditable Requirements project, set-up to complete the implementation of the new Pharmacovigilance legislation and to deliver the new EudraVigilance system. He is also supporting all activities related to the data management and analysis of the EudraVigilance (EV) system in particular using the EudraVigilance Data Analysis System (EVDAS) and SAS.

  • 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.

  • Nick  Halsey

    Nick Halsey

    • Scientific Administrator, Data Collection and Management
    • European Medicines Agency, United Kingdom

    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.

  • Esteban  Herrero-Martinez, PhD

    Esteban Herrero-Martinez, PhD

    • Director Regulatory Policy and Intelligence
    • Abbvie Ltd, United Kingdom

    Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, previously ABPI lead for PV & regulatory. Education & employment history: Biochemistry BSc from Warwick University, Virology PhD from University College London, Virology postdoc at Imperial College London and PV manager at P&G Pharmaceuticals for 5 years.

  • Barry  Mulchrone

    Barry Mulchrone

    • Director, Marketed Product Safety Services, Lifecycle Safety
    • IQVIA, Ireland

  • Anna  Pavlou

    Anna Pavlou

    • Lawyer
    • Sidley Austin LLP, Belgium

  • Agnès  Saint-Raymond, MD

    Agnès Saint-Raymond, MD

    • Head of International Affairs (ad interim), Head of Portfolio Board
    • European Medicines Agency (EMA), United Kingdom

    MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio Board since Aug 2013. Head of International Affairs (a.i.) since Nov 2016.

  • Saad  Shakir, MD

    Saad Shakir, MD

    • Director
    • Drug Safety Research Unit, United Kingdom

    Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications on pharmacovigilance and pharmacoepidemiology.

  • Willemijn M Van Der Spuij, MSc

    Willemijn M Van Der Spuij, MSc

    • Director International Operations & PV Excellence
    • Bristol-Myers Squibb, Switzerland

    Willemijn has been working in the Industry for 18 years and has been in BMS for 12 years holding various functions in Global Pharmacovigilance. Currently she is Head of International Operations and PV Intelligence. Willemijn received a Degree in Nursing from the Netherlands and a BA in Sociology from Goldsmith’s college, UK. She read her MSc in Pharmacovigilance at the University of Hertfordshire, UK

  • Sue  Rees, MS

    Sue Rees, MS

    • EU QPPV, Executive Director, Global Patient Safety
    • Amgen Ltd, United Kingdom

    Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV, based in Cambridge, UK. Sue is an honorary Fellow of PIPA and sits on the Efpia PV Expert Group. Prior to joining Amgen Sue spent 3 years at Eisai Europe as Head of International PV and EU QPPV having previously held roles in safety, medical information and marketing for GSK and AZ operating at both the affiliate and global level. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology.

  • Kiernan  Trevett

    Kiernan Trevett

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

    Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP) and has had a role in the training of GPvP Inspectors in other EU Member States. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton and a Post-graduate Certificate in Pharmacovigilance.

  • June Munro Raine, MD, MSc

    June Munro Raine, MD, MSc

    • Director - VRMM & Chairman of the PRAC
    • MHRA, United Kingdom

    Regulatory physician with experience in risk management and special interests in risk communication, access to medicines and information to patients: Chairman of the European Pharmacovigilance Working Party and member of the WHO Advisory Committee on Safety of Medicinal Products.

  • 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.

  • 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.

  • Emil Andrei  Cochino, MD, MHS

    Emil Andrei Cochino, MD, MHS

    • Scientific Officer, Anti-infectives and Vaccines, SRM Department
    • European Medicines Agency (EMA), United Kingdom

    Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Scientific and Regulatory Management Department as a Risk Management Specialist, where he is responsible for peer-reviewing risk management plans for centrally authorised products (anti-infectives and vaccines). Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and revision 2 of the EU RMP Template.

  • Leen  Verbert

    Leen Verbert

    • PV QA & Training Director
    • GlaxoSmithKline Biologicals, Belgium

  • 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.

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