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.

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

Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

Doris Stenver is the founder of Unique Advice and she is specialised in internal medicine and has a master degree in public administration. She is former Chief Medical Officer at the Danish Medicines Agency and former member of the EU Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.

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, ISoP Board Member and VP in the Alliance Clinical Research Excellence and Safety (ACRES) . He chairs the unique Pharmaceutical ergonomics & human Factors Group in the UK. After 14 years at NDA Regulatory Science Ltd, he has his own pharmacovigilance consultancy Husoteria Ltd

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.

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.

Angela has almost 20 years experience in PV with 15 years of functioning as a (deputy) QPPV. She provides customized pharmacovigilance support, including QPPV provision & responsibility for the clients pharmacovigilance systems. After her PhD in 2005, she started her career in pharmacovigilance & in 2008, she joined Organon to gain experience in PV during the different mergers taking place at that time. In 2010, she joined DADA Consultancy to start up a department of PV consultants to take on global and local responsibilities from clients in need of PV support. Her personal interests lie with Compliance management and auditing, as well as Risk Management and Medication Errors, & she recently obtained a MSc in Clinical Epidemiology.

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015. From 2022 he also has the same role for Alexion. Based in Gothenburg, Sweden he joined the company in 2002 and have had several specialist, oversight and line managerial roles within the global 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.

Maarten Lagendijk is the deputy QPPV at MSD since 2019 and is based in the Netherlands. Maarten has over 20 years of experience in pharmacovigilance. He has previously worked for the Medicines Evaluation Board in different pharmacovigilance related roles as well as a national expert at the European Medicines Agency.  Maarten has been involved with DIA for many years and is part of the programme committee for the Global QPPV Forum since 2020. 

Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009 and joined PRAC at its establishment in 2012. As a member of EMA’s GPAG (Granularity and Periodicity Advisory Group) and SMART WG (Signal Management Review Technical working group) and of CMDh’s PhV WSP WP (Pharmacovigilance Worksharing Procedures Working Party), he has a special interest in PSURs and PSUSAs, signal detection and management, and Risk Management Planning.

Helen Powell has over 30 years’ experience in the pharmaceutical industry in large pharma, CRO and consultancy sectors, the majority of time in QA conducting audits in GCP, Pharmacovigilance and auditing of corporate legal risks. Prior to becoming an auditor, Helen worked in laboratory research, as a sales representative and a Clinical Research Associate. She has managed global audit teams across the USA, Asia Pacific and Europe, as well as facilitating Pharmacovigilance and GCP inspections in these territories.

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.

Dionne is based in the UK and works in MSD's Office of the Global Qualified Person for Pharmacovigilance (GQPPV). Dionne is MSD's PSMF Owner and supports various key Global/EU and UK QPPV projects and tasks, such as EudraVigilance access, audits and inspections support and general project management, as needed. As a member of various PSMF industry groups, they share a keen interest in all things PSMF and the various approaches that companies take towards ensuring an efficient and compliant approach to PSMF management for the EEA, UK and globally.

Willemijn is the Executive Director Europe in the WorldWide Patient Safety Organisation in Bristol Myers Squibb. She is responsible for Patient Safety in the European region, including the Balkans, Baltics and distributor markets. Prior to this role she was responsible for the European markets, PV Intelligence & International Operations including the PSMF as well as Training and Outsourcing activities. Willemijn holds a Nursing Degree from the Netherlands, a BA (Hons) in Sociology from Goldsmiths college, University of London, UK and an MSc in Pharmacovigilance from the University of Hertfordshire, UK. Willemijn is co-chair of the EFPIA Pharmacovigilance Expert Working Group and Chair of the EFPIA International Pharmacovigilance Group.

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.

Jane Feron BSc (Hons) has spent most of here working life in the pharmaceutical industry. After working in Clinical Research for nearly 10 years, she joined the PV department at AstraZeneca. She worked in safety surveillance before becoming the process owner for Risk Management and subsequently taking the role of PV processes lead, where she was responsible for all the PV processes at AstraZeneca. Currently she is a Risk Management Director and is responsible for developing risk minimisation strategies primarily for the oncology portfolio, supporting affiliates in the implementation of local risk management regulations and risk minimisation measures, and maintaining global oversight of risk management activities internally and externally.

Sue is a former EU QPPV and established expert in pharmacovigilance in Europe, with over 30 years’ pharmaceutical industry experience across a number of organisations including GSK, AstraZeneca and Amgen and served on the EFPIA PV Expert Group for 10 years. As an independent consultant, Sue now shares her knowledge and expertise with organisations through interim leadership, consultancy projects and training. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology and is a Senior Lecturer at the University of Hertfordshire for the post graduate Pharmacovigilance Master’s degree course.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads 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.

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.

Randip Kahlon is the Global Risk Management Therapeutic Area Lead for Oncology at Bristol Myers Squibb, with 20 years experience in pharmacovigilance and risk management. He has co-authored scientific publications on risk minimisation effectiveness evaluation studies and presented on digital approaches for risk minimisation at several external conferences. Randip holds a BSc (Hons) Degree in Medical Biochemistry and Diploma in Professional Development, both from Brunel University London.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

I am a Physician who qualified and practiced intensive care medicine in the UK, before joining the Pharmaceutical industry. I occupied several positions in Clinical Research, including Country Medical Department and Clinical Research Operations management based in the UK, Belgium and the USA. I entered PV full time as the EUQPPV based in Belgium where I was involved with EFPIA during the implementation Phases of the EU PV modules and co-authored several papers: and subsequently moved back to the USA to lead a Clinical Safety Franchise, I am Currently Head of Global Pharmacovigilance. I was delighted to participate in the Transcelerate Value of Safety Information which has provided valuable data around the relative utility of ICSR sources.

Tim designs and implements global operating models for Multinational Companies (Value Chain Management). He leads KPMG’s response to Brexit across tax, the Life Sciences and industrial sectors. In the last decade a particular focus of Tim’s has been on developing an integrated tax, commercial and operational approach to transformation projects. In addition to his Brexit roles, Tim is a member of KPMG’s core teams responding to the OECD Base Erosion and Profit Shifting (“BEPS”) initiative. He lectures regularly at Cranfield School of Management as part of a partnership between the university and KPMG.

Yusuf is the Deputy EU QPPV for Roche since 2018 and is based in Grenzach-Wyhlen in Germany. He has been with multiple international pharma companies in his career, spending more than a decade in pharmacovigilance. With a background in Bioinformatics, he had previously helped multiple organisations to set up their statistical signal detection and management systems, and gained experience in early drug development as well..

Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

Martijn started his career in Pharmacovigilance in 2005 with Organon, later taken over by Schering-Plough and subsequently MSD. During this time he held various roles with increasing responsibility in Clinical Risk Management as well as PV Operations, and was involved in massive integration activities related to the company’s mergers. In his last role at MSD, he was a PV Lead and PV Liaison, aligning case management processes and providing PV training worldwide. In 2014 he joined Vifor Pharma as Deputy EU QPPV. As of 2018 he is also the Global Head of Drug Safety Compliance, a role in which he is responsible for PV Compliance Management, Regulatory Intelligence, PV training, Contractual Compliance and the company’s PSMF.

Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

David Stokes has more than 30 years’ experience in the Health Sciences industry and is an internationally recognised thought leader in the fields of computer systems validation & information systems compliance. He has consulted widely in R&D, clinical, manufacturing, post marketing surveillance and sales/marketing. He is experienced in regulatory compliance in a variety of domains including GMP, GCP, GLP, GVP, health care, reduced risk tobacco (RRP) etc. His ‘sweet spot’ is in solving problems where leading edge information systems technology meets innovative but regulated business processes and he applies his significant experience to ensure that mission critical projects are established and run in a compliant and efficient manner.