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

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. 

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.

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.

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.

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

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.

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.

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.

Anastasia has been working at the MHRA for 5 years. Her PV experience ranges from product information quality and safety variations, ICSR case processing, signal assessment and management, as well as governance. More recently Anastasia has joined the PV inspector team at the MHRA to focus on compliance. Notable career highlights includes appointment as one of the first COVID-19 vaccine safety assessors monitoring the benefit-risk profile post vaccine roll-out. Her academic background is in biochemistry.

ANNA-SHARI MELIN is a leader of the Global Life Sciences practice in Munich. She is focused on EU & German regulatory compliance, ESG, & private equity/M&A. Her clients span pharmaceuticals, biotechnology, medical devices, food, cosmetics, and consumer goods. With extensive experience in product lifecycle regulatory matters, she advises on clinical trials, GMP compliance, PV supply chain management, marketing, and compliance issues, as well as due diligence for life sciences transactions. Representing clients before EU & German authorities, she has handled notable cases, including pay-for-delay appeals. She co-leads Sidley’s PV benchmarking group & the Life Sciences ESG Roundtable, fostering discussion on evolving EU ESG regulations.

Chimwemwe Chamdimba leads the African Medicines Regulatory Harmonization (AMRH) Initiative at AUDA-NEPAD, overseeing the programme and supporting the operationalisation of the African Medicines Agency (AMA). A health policy specialist, she drives regulatory reforms that strengthen systems, align with procurement, and boost local manufacturing. She has contributed to key AU policy frameworks, including the Model Law on Medical Product Regulation, the AMA Treaty, the AU Health Strategy, the Private Sector Engagement Framework, and STISA-2024.

Medical Doctor with substantial Industry experience in global Drug Safety & Pharmacovigilance. Values a lifecycle integrated benefit-risk management approach, transparency, diversity, building cross-functional relationships and putting patients first. After a career at UCB Pharma and GSK Vaccines, joined Janssen Pharmaceuticals in 2016 as a Medical Safety Officer before joining the Office of the QPPV in 2019. Currently the Janssen deputy EU QPPV and Head of the PV System Oversight team.

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.

Dr Liana Martirosyan is a medical doctor with an MPH and a PhD in pharmacoepidemiology. She represents the Netherlands at the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and serves as its Vice-Chair. Liana joined the Medicines Evaluation Board (MEB) in 2012, where she worked as a pharmacovigilance assessor before becoming a PRAC member. Her special interests include interventions in clinical practice to minimise drug safety risks and the evaluation of the effectiveness of additional risk minimisation measures.

Deirdre is a Senior Program Officer and Pharmacovigilance Lead at the Gates Foundation, overseeing grants that support the African Union’s first continental safety surveillance platform for the African Medicines Agency. With over 20 years of PV experience across regulatory, industry, and non-profit sectors in the EU, US, and Latin America, she brings a global perspective to post-marketing safety, compliance, and global health. She has lectured at Tufts University and is a Fellow of the International Society of Pharmacovigilance (ISoP).

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision of ICH GCP E6 (revision 3) and Chair of the GCP Inspectors' Working Group. He previously held inspection and management positions at the Irish Health Products Regulatory Authority (HPRA) and UK-MHRA, and positions in pharmacovigilance, medical affairs and good distribution practice in industry. He holds a BSc and Masters degrees in pharmacy, and two Bachelor of Laws degrees.

Mr. Demeke Amare is a Pharmacist and Regulatory Affairs expert with over 14 years’ experience in pharmacovigilance, clinical trials, quality control, and regulatory inspections (GMP, GCP, GLP, GVP). He currently serves as a Medicine Safety and Post-Marketing Surveillance Expert at the Ethiopian Food and Drug Authority (EFDA). Demeke holds a Master’s in Clinical Trials and has held several senior roles at EFDA, including QPPV focal point. He has contributed to key regulatory initiatives with WHO, AUDA-NEPAD, and others, and has participated in international forums across Africa, Asia, Europe, and the Middle East.

Christine is the Good Clinical Practice and Pharmacovigilance Inspection Manager at the HPRA. She has 8 years’ experience at the HPRA, holding positions within the Human Products Monitoring department as a Pharmacovigilance Assessor and within the Compliance department as a GCP/PV Inspector and GCP/PV Inspection Manager. Christine is the Irish member of the EMA Pharmacovigilance Inspectors Working Group (IWG) and Irish alternate member of the EMA GCP IWG. She is also an active member of the Pharmaceutical Inspection Co-operation Scheme (PIC/s) GVP Expert Circle - Artificial Intelligence and Machine Learning Working Group. Prior to joining the HPRA, Christine worked in industry where she gained experience in Pharmacovigilance

Marketed Product Safety Ass. Director at IQVIA, with more than 10 years pharmacovigilance experience, including both CRO and Pharmaceutical industries. Oversight of Local QPPV Global Network.

Responsibility to lead the strategic positioning & direction of Pharmacovigilance (PV) quality & compliance across AbbVie's global PV QMS. Act as an expert in critical assessment & interpretation of PV compliance regulations, and consequential internal PV policy and process determination. Previously worked at the UK's MHRA, holding a variety of positions, including PV Inspectorate Operations Manager & Senior PV Inspector, and other roles in the Enforcement and Post-Licensing Divisions. Took a lead role in the publication of the MHRA's Good Pharmacovigilance Practice Guide and also contributed to the development of the EU Good Vigilance Practice modules. Carrie has also held other PV Compliance and Quality Assurance roles in the Industry.