Françoise is a medical doctor as background, working in Pharmacovigilance for more than 30 years in big Pharmaceutical companies with different managerial roles, interactions with Health Authorities, and coordination of international networks of Pharmacovigilance. She has spent 15 Years on Vaccine Pharmacovigilance where she contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. Within the EFPIA Pharmacovigilance expert group, she analysed the influence of EU pharmacovigilance regulations outside Europe and of non EU regulations on the EUQPPV role.

Over the past 25 years Wendy has been dedicated to pharmacovigilance. She has broad experience as EU QPPV for generic and innovative products in complex companies. She also has wealth of experience in lobbying and networking in trade associations/working groups. In her current role, Wendy provides pharmacovigilance support to Pharmaceutical Industry and SMEs (startups). She enjoys setting up the PV system and supports in the development of the PSMF with associated documents. Since 2020 Wendy is a trained professional in Transactional Analysis (TA). TA is a theory of human personality and social behavior. TA gives a wealth of options to work with challenges and changes in organisational and personal development.

Shahin Kauser also has a Certificate in Pharmacoepidemiology & Pharmacovigilance from the London School of Hygiene and Tropical Medicine. Shahin is a Leading Senior Scientific Assessor and joined the MHRA Agency (former MCA) in 2001. She has extensive experience of the ‘life-cycle’ of pharmacovigilance both nationally and in Europe. Her current portfolio includes monitoring the post-marketing safety of medicines in various therapeutic areas including blood disorders, multiple myeloma and malignant melanoma. Shahin has expertise in assessing benefit/risk, PSURs, safety Variations and risk management plans, additional risk minimisation measures and assessing their effectiveness.

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. 

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.

James has extensive experience in pharmacovigilance and patient safety, with his most recent role on the Patient Safety Operations Leadership Team at AstraZeneca as Senior Director Device and Digital safety. In the past, James has been a Life Science Consultant, a Safety Scientist performing safety risk/signal management and a case processor. James holds a BSc in Psychology and an MSc and MBA with a focus on Patient Safety. In addition, he contributed actively to industry-wide initiatives through DIA and Transcelerate.

Esther de Vries is a pharmacovigilance assessor at the Dutch national agency (MEB), while finishing her PhD at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) in the hospital setting in the Netherlands. In addition to these activities, she is involved in digitalising the DHPC in the Netherlands.

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.

Andrej Segec is a pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has worked for the European Medicines Agency since 2008, in pharmacovigilance/signal management, monitoring of the EMA pharmacovigilance system, in surveillance and epidemiology, as committee manager for the operations of the Pharmacovigilance Risk Assessment Committee (PRAC) and as a risk management specialist for anti-infective therapies and vaccines during the COVID-19 pandemic.Currently, Andrej’s focus is on the generation and use of RWE in regulatory decision making and the establishment of the DARWIN EU®.

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.

Carla Jonker has obtained a master's degree in biomedical sciences at the University of Leiden. Currently she combines her position as Senior Regulatory Project Leader at the Medicine Evaluation Board in the Netherlands with her work as National Expert in the Real World Evidence department within the Data Analytics and Methodology Task Force at the European Medicine Agency. She has over 20 years’ experience, both in industry in different positions and at the Medicine Evaluation Board. Her work experience includes multiple topics related to the benefit-risk assessment of medicinal products and a PhD research at the University of Utrecht to investigate the value of rare disease registries for regulatory decision-making.

As a Biopharmaceutical Scientist and Business Developer, Arian bring a unique blend of scientific expertise and entrepreneurial spirit to the table. With an MSc in Biopharmaceutical Sciences and Indiustrial Pharmacy from Leiden University and over 8 years of experience in pharmaceutical innovation, R&D, and technology, he has a track record novel market development.

Lutz Naehrlich is a pediatric pulmonologist and works as a consultant Departement of Pediatrics, Justus-Liebig-University Giessen, Germany. His research focus are the iagnosis and epidemiology of Cystic Fibrosis. He is the medical lead of the German CF Registry and the Pharmacovigilance Study manager of the European Cystic Fibrosis Society Patient registry.

Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit-risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

Kristel Van de Voorde is a pharmacist and has more than 25 years of experience in the quality area covering GCP,GVP and interfaces in R&D with GLP and GMP. Currently, Kristel is the global head of the quality function for pharmacovigilance at GSK. Her main responsibilities are to oversee the strategy and execution of the audit schedule related to pharmacovigilance, manage health authority inspections and support building a strong Quality Management System aiming for proactive risk identification.

Elodie Aubrun is Group Head of Quantitative Safety and Epidemiology (QSE) at Novartis since August 2018, specializing in pre- and post-marketing epidemiology and safety strategy for products in Respiratory, Global Health, and Immunology. Previously, she was Associate Director of Epidemiology and Outcome Research at IQVIA. A member of ISPE and CIOMS working group XIII on Real World Evidence, Elodie has 16 years of experience in pharmacoepidemiology across pharma companies and contract research organizations. She holds a PharmD, MSc, and MPH from University Paris XI, France.

Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.

Jean Kilgour-Christie has been in the Pharma industry for more than 30 years with experience across Pharmacovigilance and also spending a time in Regulatory Operations. She has worked in several large Pharma companies. Her most extensive and recent experience is in role of EU Deputy QPPV, UK QPPV & Head of Audits and Inspections.  In addition, She has worked on many external projects and represented companies she is worked with, on external industry forums, most recent on Medicines for Europe.

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.

Ryan has over 10 years’ experience in the field of patient safety and medicines development, in both CRO and big pharma environments, encompassing clinical and post-marketing products across a broad range of therapeutic areas. Most recently, Ryan has specialised in risk management implementation, successfully leading and coordinating complex global risk management strategies including digital elements to plan.

Lina van Hout has more than 20 years experience at several production sites in hospital pharmacies. Currently she works at the Catharina Pharmacy Production Unit, which manufactures medicines that pharmaceutical industry cannot or will not make.

Domenique is manager Research and Quality of Care at the Dutch Cystic Fibrosis Foundation (NCFS). The NCFS plays a central role between all stakeholders involved in CF. One of the main tasks of Domenique is coordinating the Dutch CF Registry, existing since 2007. She is also a member of the Executive Committee of the European CF Patient Registry. Domenique is a pharmaceutical scientist by training and obtained her PhD in 2018.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research".