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The Crystal

Oct 04, 2016 1:00 PM - Oct 04, 2016 6:00 PM

1 Siemens Brothers Way, Royal Victoria Dock, London, E16 1GB, United Kingdom

Introduction to the role of QPPVs

Instructors

Elspeth  McIntosh, MBA, RN

Elspeth McIntosh, MBA, RN

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 post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Christopher J. Foreman, JD, LLM

Christopher J. Foreman, JD, LLM

Deputy Chief Privacy Officer, Global Privacy Office, Merck Sharp & Dohme (Europe) Inc., Belgium

Chris Foreman is the Deputy Chief Privacy Officer of the US-based Merck & Co., Inc. He is a lawyer, having spent 20 years in the Company’s Office of General Counsel, before joining the Global Privacy Office in Sept. 2018. Based in Brussels, Chris has practiced law in London, Washington DC, Istanbul, New York, Brussels and Moscow, focusing on pharmacovigilance, pharmaceutical regulations, trademarks and general corporate work.

Jefferson C.E. Guillon

Jefferson C.E. Guillon

Pharmacovigilance Manager & EEA QPPV, Alliance Pharma Plc and Alliance Pharmaceuticals Ltd, United Kingdom

Jeff is currently the Pharmacovigilance Manager and EEA QPPV for Alliance Pharmaceuticals Limited. Jeff has been at Alliance for over 10 years, and has been QPPV at Alliance for 7 years. Jeff has been in the pharmaceutical industry for over 14 years, 11 of which have been in Pharmacovigilance. Jeff holds a MPhil in cellular pharmacology.

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.

Magnus  Ysander, MD

Magnus Ysander, MD

EU & UK QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and have had several specialist, oversight and line managerial roles within the AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Janet  Scott, MSc

Janet Scott, MSc

Senior Consultant (Pharmacovigilance), Xendo-Vigilex, Netherlands

Janet is pharmacovigilance professional with over 25 years’ experience in the pharmaceutical industry. She has extensive pharmacovigilance experience across the full breadth of PV activities acquired from various diverse operational, leadership and management roles at GlaxoSmithKline (and heritage companies) and Eisai Europe. She currently works for Xendo-Vigilex as a Senior Pharmacovigilance Consultant where she fulfils the QPPV/deputy QPPV role as well as providing support to many QPPVs throughout Europe (in a companies of all sizes) with PV auditing, inspection readiness and on guidance on establishing/maintaining quality and complaint PV systems.

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

Peter  De Veene, MD

Peter De Veene, MD

GQPPV, MSD Belgium, Belgium

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.

Michael  Richardson, MD, FFPM, FRCP

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety , 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.

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