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

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.

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.

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.

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.

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.

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.

Calogero Cannavo is a trained pharmacist with a Master’s degree in Regulatory Affairs. He joined the EMA Inspection Office in 2016 as a Scientific Administrator, after beginning his career as a pharmacovigilance inspector at the Italian Medicines Agency. He currently serves as the chair of the Pharmacovigilance Inspectors Working Group at EMA.

Antonio is a PV professional expert with over 18 years of experience in the pharmaceutical industry. Currently, he serves as the PV System Excellence and QPPV Support at BMS. Within the BMS QPPV office, he is responsible for providing the EU QPPV with consistent PV System Oversight. He oversees PV excellence initiatives to facilitate strong local connection through central coordination, supporting the PV mission with dedication and expertise. He is also responsible for Global PV Regulatory Intelligence. Antonio is dedicated to delivering safe medicines to patients, a commitment that has been a cornerstone of his career since starting at Pfizer. This commitment became a reality while working at Celgene on thalidomide and continues at BMS

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.

With over 15 years in the pharmaceutical industry, Suzanne specializes in gene and cell therapy safety surveillance at Novo Nordisk A/S. As Safety Surveillance Principal Specialist, she developed a safety strategy aligned with regulatory standards for cell therapy projects targeting Parkinson’s disease and Type 1 diabetes. Her extensive pharmacovigilance background includes leading an EFPIA PVEG subgroup on cell and gene therapy products. Suzanne has also spoken at the Axian Forum, co-authored a paper on text mining for signal detection, served as an Associate Professor at the University of Copenhagen, and contributed as a pharmacovigilance expert to the European & Developing Countries Clinical Trials Partnership (EDCTP).

Anne is an M.D who started as a physician in Hospitals prior moving to Pharmaceutical Industry. She  has gained over 25 years of experience in both pharmacovigilance and clinical safety in various therapeutic areas. She has done most of her carrier for a French Company Pierre Fabre where she was responsible for a broad range of pharmacovigilance activities and acted as Deputy QPPV.  Anne joined the QPPV Office team of AstraZeneca in 2022 as EU & UK Deputy QPPV.

Dr Dave Lewis is Visiting Professor of Pharmacovigilance within the School of Life and Medical Sciences at the University of Hertfordshire, UK. Dave worked for over forty years in Patient Safety and Pharmacovigilance at GSK, Shire and Novartis. He was an active contributor to the ICH E2B (electronic reporting) and E2D (post-marketing data management) Expert Working Groups. He led the Innovative Medicines Initiative WEB-RADR project focusing on pharmacovigilance and social media, and was Co-Lead for Work Package 2 of the IHI ConcePTION project, researching pharmacovigilance in pregnancy and breastfeeding. PUBLICATIONS: Bibliography of ~40 publications on pharmacovigilance can be provided upon request.

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.

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.

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.

Jens-Ulrich Stegmann, MD, RN, is Senior Vice President, Head of Clinical Safety and Pharmacovigilance, and EU QPPV at GSK, Belgium. With an M.D. in nursing from the University of Essen and a Ph.D. in Physiology from Christian-Albrechts University in Kiel, Germany, Jens began his career as an anesthesiologist and emergency doctor at the University of Düsseldorf. He later joined Grünenthal, contributing to analgesic development before moving into Safety in 2008. Joining GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management, he became Deputy EU-QPPV, then Head of Clinical Safety and Pharmacovigilance. In 2019, he assumed the role of EU-QPPV for GSK and ViiV Healthcare and advanced to his current role in 2020.

Fabian Heisig is leading the Global Drug Safety Department at Grünenthal since 2018 and was appointed as EU QPPV and UK QPPV. In addition, he is deputizing the Chief Medical Officer. He started his career at Grünenthal in 2007 and had various roles incl. leadership responsibilities in case processing, benefit risk management and clinical safety. He has expertise in the pre-marketing area as well as in the post-marketing area. He is a member of EFPIA Pharmacovigilance Expert group.

Experienced pharmacovigilance professional with 25+ years of Headquarter pharmacovigilance experience. QPPV-function and PSMF. Profound knowledge of global pharmacovigilance legislation, compliance, impact assessments, pharmacovigilance processes and systems. Demonstrated experience with audits and inspections within PV, GCP and GMP areas. Strong communication skills, analytical skills and quality mindset. Management, training and mentoring.

Myriam Salem is currently coordinating the Good Pharmacovigilance Practices inspection Program at Health Canada. She previously worked as a pharmacovigilance scientific manager and a senior scientific evaluator for several years. She was involved in the implementation of several policies leading to a strengthened post market oversight of opioid products in Canada. Prior to joining Health Canada, she held various positions in the pharmaceutical industry and academia. She is a biochemist by training and holds a master’s degree in pharmacology from Université de Montréal and a master’s degree in Pharmacovigilance and Pharmacoepidemiology. She is the chair of the PIC/S GVP international working group on Artificial Intelligence-Machine learning.

Kerstin is a licensed pharmacist specialised in drug information and holds a PhD in pharmacology. She is working within the BfArM for more than 24 years in different positions and is head of the PV-inspectorate at BfArM since 2017. She was member of different working groups of the European Commission and EMA and was involved in developing guidelines.

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.

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates the Health Data Lab at the European Medicines Agency and has several functions related to enabling the safe and responsible use of AI with healthcare data, including RWD. He has worked in the field of pharmacovigilance and drug safety for over 22 years, in academic and regulatory settings.

Yoon Jeon (Jamey) Kim, the Director and North Cluster PV lead for Latin America at MSD, has 23 years of experience with the company. She provides strategic leadership for cluster countries (Colombia, Ecuador, Venezuela, Central America, and the Caribbean), with an extensive background in pharmacovigilance, regulatory affairs, and clinical trials. Additionally, she chairs the post-approval safety monitoring program review committee within the company. Previously, she held roles as Country PV lead and Regulatory Affairs manager at MSD Korea. She is a pharmacist with a master’s degree in pharmaceutical technology and a bachelor’s degree in pharmacy from Ewha Womans University in South Korea.

Doaa Soliman holds a B.Sc. in Pharmaceutical Science, an Egyptian Board of Healthcare Management certification, and a Master’s in Healthcare Quality Management. With 10 years of experience in the healthcare sector, Doaa has worked as an inpatient and community pharmacist, as well as in supply chain management, specializing in pharmacovigilance (PV). As an Administrative Manager, she oversees three units: PV Training, PV Inspection, and Pharmacovigilance System Master File (PSMF) Assessment. She has contributed to the Egyptian Drug Authority's (EDA) global benchmarking program with the World Health Organization (WHO) and led PV inspections across Egypt, ensuring compliance with safety standards.

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.