Julia is a senior pharmacovigilance professional with over 23 years of global experience across the pharmaceutical, biopharmaceutical, and CRO sectors. She has served as the EU QPPV and held leadership roles in regulatory intelligence and pharmacovigilance strategy at large pharmaceutical companies. Julia is also recognised as an AI expert in pharmacovigilance and a strong advocate for innovation in drug safety. She is a published author, international speaker, and contributor to the EMA AI Working Group on the General-Purpose AI Code of Practice.

Dr. Mina Ebeid has over a decade of experience in the pharmaceutical and biotech industries. He is currently serving as the Global Drug Safety and Pharmacovigilance Signal Detection Lead at Genmab where he drives safety strategies and leads the company in innovative Pharmacovigilance Digital Solutions. During Dr. Ebeid’s tenure, he has supported BLA filings for oncology medications such as Enhertu and Epkinly. Dr. Ebeid’s passion lies in driving innovative technological advancements combined with medical expertise.

Michael Alexander Harborg holds a MSc in Engineering with a specialization in Applied Mathematics and Machine Learning. He graduates with honours from the Technical University of Denmark (DTU) in 2025. Michael worked in Genmab from February 2023 to July 2025 and lead the early development on source code that performs statistical analyses and machine learning in GenSignal, an internal Genmab platform for performing pharmacovigilance. Besides working in Genmab during his MSc degree, Michael founded a company that specializes in building machine learning models from the ground up tailored to other companies’ needs.

Philip Jones is a physician-scientist with over 15 years of industry experience in PV. He is Disease Area Cluster Lead in Safety Surveillance and Risk Management (SSRM) at Pfizer leading a global team of safety physicians managing the benefit-risk profiles of medicines. He leads the SSRM AI Group exploring the use of AI & automation in signal management, literature review & predictive safety & also Co-chairs the Pfizer Hepatic Injury Council. He has multiple publications in biomedical journals, several years of experience in clinical practice & is a regular speaker at international conferences.

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.

Nicole M. Schmid Davis is an experienced pharmacovigilance professional with over two decades of combined clinical and drug safety expertise. At Genmab, Nicole is responsible for designing and implementing surveillance plans that integrate traditional methodologies with AI-enabled approaches to detect and evaluate emerging safety signals. Her work directly informs critical regulatory deliverables including DSURs, IBs, RSIs, REMS, and RMPs. She is also actively engaged in advancing pharmacovigilance innovation, with a strong focus on operational excellence, inspection readiness, and the strategic application of digital tools in signal management.

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.