Gemma Jiménez Sesé currently holds the position of Deputy EU and UKQPPV at Astrazeneca, based in Barcelona, Spain. Previously, she served as the EUQPPV at Almirall. With over 20 years of experience in pharmacovigilance, she has taken on roles with increasing responsibility. In pharmacovigilance, she has been involved in a broad scope of activities, encompassing safety in clinical development and support for marketed medicinal products, including small molecules and biologics. Beyond safety, she has led projects in late-phase development and product life-cycle management. Additionally, she is a member of the Program Committee for the DIA QPPV Forum

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.

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.

Shahinaz, a pharmacist with over 20 years in pharmacy and the pharmaceutical industry, is a Pharmacovigilance Consultant and Lead Auditor across the EMEA region. She began as a clinical pharmacist at Cairo University Medical School and advanced to an internal auditor role. Transitioning to the pharmaceutical industry, she worked in Regulatory Affairs before specializing in Pharmacovigilance as a regional QPPV and later as a PVQA Lead Auditor. Shahinaz is active in the ISOP Special Interest Group, contributing to global pharmacovigilance certifications, and frequently speaks at international conferences on patient 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.

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. 

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.

Katarzyna qualified as a pharmacist and joined GlaxoSmithKline in 2017 as the Safety Evaluation Risk Management Scientist in a central team supporting established products. She is responsible for a broad range of pharmacovigilance activities, such as the global signal detection, preparation of periodic safety reports, RMPs and safety input to queries from regulatory agencies. Katarzyna has been extensively involved in associative work throughout her whole pharmacy studies, up to the European level when she was the President of the European Pharmaceutical Students’ Association (EPSA), representing 160 000 European pharmacy students and young professionals.

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. 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.

Claire is the Expert Pharmacovigilance Inspector at the MHRA. She has 10 years experience at the MHRA holding various positions within the MHRA Compliance Teams. Claire has led multiple high profile inspections as well as given a variety of presentations and talks at numerous events in the UK and overseas. In Claire's current role as the Expert Inspector, she is responsible for developing the strategy of the GPvP Compliance Team and aligning this with other GxPs across the MHRA. Prior to joining the MHRA Claire worked in Industry where she gained experience in a number of aspects of Pharmacovigilance and Medical Information.

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.

Helen Fiddes, Head of Patient Safety, UK and Ireland at Bristol-Myers Squibb, based in Uxbridge, United Kingdom. Managing a team of nearly thirty Pharmacovigilance professionals, working on a diverse portfolio including three Pregnancy Prevention Programmes for thalidomide and its derivatives. Been in the industry and pharmacovigilance for over 20 years. Prior to that community pharmacy, after graduating from the University of Strathclyde, in Glasgow.

James Whitehead is the Senior Director, Device & Digital Safety at AstraZeneca working within Global Patient Safety, having started his career with AZ as a Pharmacovigilance Scientist in Oncology. Since graduating with a BSc in Psychology from the University of Leicester, James has held positions at CROs, Pharmaceutical Companies and Consulting Practises with a focus on Signal and Risk Management. That passion for Signal and Risk Management culminated in a MSc in Pharmacovigilance from the University of Hertfordshire, James is now a Visiting Lecturer on the course. Recently, James studied for an MBA and focused this project on innovation and digital transformation within Patient Safety.

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. She was the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC) from 2012 till 2018 and acted as PRAC chair from July 2018 till July 2024. She also 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.

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is a service provider and associate department of the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.

Clare works in the QPPV Office and has been the AstraZeneca PSMF Coordinator for the past seven years. Other Pharmacovigilance related activities include EudraVigilance access management and PRAC monitoring. Prior to joining AstraZeneca Clare enjoyed an extensive Regulatory Affairs career for companies such as Boehringer Ingelheim and Johnson & Johnson.

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.

Michelle is leading the International Pharmacovigilance organization at MSD. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining MSD in 2002 she has performed various roles within PV including an EUQPPV support function, as well as prior regional operations roles in Asia Pacific and EMEA. Michelle has accountability for PV activities ex-US which consists of approx. 205 markets managed from 56 locations across the globe. Michelle is a part of the Global Clinical Safety and Pharmacovigilance Leadership Team, and works closely with HQ colleagues in the US. She is based in Europe.

Ruth is a registered pharmacist who joined AstraZeneca in 1999 after completing her pre-registration training in hospital pharmacy. After several years working in a number of formulation development and regulatory CMC roles, she joined the Pharmacovigilance department in 2007. Ruth worked in the Safety Surveillance Group before moving on to become the process owner for a number of Pharmacovigilance processes including Safety Surveillance and Risk Management. Currently Ruth is a Pharmacovigilance Excellence Expert where, since 2017, her main responsibilities include support to the EU QPPV on process related matters and leading continuous improvement projects relevant to the content quality of key Pharmacovigilance deliverables.

Jessica is the Director of Patient Safety Excellence and an expert PV advisor in the AstraZeneca QPPV Office. She has been with the company for 9 years and held various roles within PV, including leading the global PV audit team. Jessica previously worked at Biogen in Switzerland as the Swiss QP and held several roles within Medical Affairs. She has thorough experience across multiple GxP areas both from a global and local perspective. Jessica holds a PhD in Immuno-oncology from ETH Zurich.

Sina is the Head of the QPPV Office & EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 14 years. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. In her free time, Sina loves spending time with her husband and two little girls and enjoys horse-riding.

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.

Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food and Drugs Authority-Ghana. Adela is involved in the strengthening of the pharmacovigilance system in Ghana through education of stakeholders including healthcare professionals and the general public. Adela’s recent works have been in assisting pharmaceutical companies in Ghana to establish efficient Pharmacovigilance systems through the training of Qualified Persons for Pharmacovigilance and the conduct of Good Pharmacovigilance Practice Inspections since 2016.

Caroline has 25+ years of experience in the pharma industry. She started her career in clinical research, in Data Management and subsequently as a Clinical Research Associate and (CRA) and a Clinical Team Lead working across a number of therapeutic areas. She embarked her pharmacovigilance (PV) career in 2010, where she worked as a local QPPV managing the local PV system & Quality Complaints. Since re-joining IQVIA in 2015 she has performed various PV roles, including heading the Global PV Agreements services with a team of 15 managing >2000 agreements, as Quality Manager supporting Regulatory Inspections and deviation/process improvement strategies, as PSMF Coordinator and more recently within the Local QPPV team as Lead and Line Manager.

Koen has over 15 years of experience in pharmacovigilance and more than 9 years as QPPV. Since summer 2021 he is the EU and UK QPPV for Galapagos, where he joined to help finalize the pharmacovigilance system in light of an upcoming transfer of a Market Authorisation. Prior to Galapagos he worked 10 years for Medtronic BioPharma, a small pharma entity in the medical device company Medtronic. Within this company he build up the pharmacovigilance system for the first pharma product of Medtronic. He has a Master in Biomedical Sciences, with a main focus on epidemiology and pathobiology.

Marylene Zhan, a senior consultant at Accestra Consulting, brings extensive expertise in pharmacovigilance and regulatory affairs. Holding a Master's Degree from Zhongnan University of Economics and Law, she excels as a bilingual and bicultural consultant, specializing in China regulatory compliance and pharmacovigilance (RA/PV). With deep insights into Chinese Pharmaceutical regulations and market access, Marylene aids international pharma companies in entering China market. Her adept communication fosters strong client relationships, ensuring top-notch services aligned with business goals.

Barbara has worked in Quality at UCB for the past 5 years. Her current role is Head of Early & Development Solutions Quality Auditing and Center of Excellence. Prior to her current position, she was EU QPPV in Mithra Pharmaceuticals. Barbara studied epidemiology, public health, social sciences and business management. She holds a PHD in Pharmacovigilance and wrote her thesis on signals and whistleblowers in health and pharma sector.

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy expert, she leads reforms, harmonization, and partner coordination, contributing to vital continental policies including the AU Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); and the AU Private Sector Engagement in Health Framework.

Pat Hawthorne works in the International Medicines Quality Organisation and is based at Eli Lilly in the UK. Primary responsibilities are leading the processes around the maintenance the EU PSMF and localised PSMFs and shaping affiliate vigilance.

Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT. Koen is currently working at Bayer as RA Policy and Innovation Lead. He joined Bayer as head of regulatory affairs and quality for the Belgium/Luxemburg region and previously has been active within MSD and Medicines for Europe in different roles in Regulatory Affairs and Quality. Within his current role as RA Policy and Innovation Lead, Koen leads the internal global e-labeling initiatives at Bayer and is vice-chair of the Inter Association TaskForce (IATF) for ePI.

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..

Rory has over ten years’ experience working at the MHRA, and two years working at GSK in Safety Governance. Rory’s experience includes engagement 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.

Lauren has nearly 10 years’ experience working in the pharmaceutical industry in a variety of quality and compliance roles. She has worked in BMS for the last 4 years just recently taking the position of Associate Director, PV Inspection Readiness & Deviation Mgmt. which will involve leading the inspection readiness, audit CAPA and Deviation management teams within the PV Compliance function of BMS. Prior to this change, she worked in the same team supporting multiple inspections globally, audit CAPA management and execution of the inspection readiness program. Prior to BMS, she worked in the PV and country organisation quality auditing departments in both Pfizer and AbbVie.