Real4Reg Final Symposium | 3–4 November 2026 | Lisbon, Portugal

Andrea De Censi graduated in Medicine and Surgery with first class honours at the Medical School University of Pavia in 1984. He went on to specialise in Medical Oncology at the Postgraduate Medical School, University of Genoa, Italy in 1987. In 2008 he earned the ESMO European Certification in Medical Oncology.

Dr De Censi became tenured assistant at the National Institute for Cancer Research in Genoa and since 1998 he worked as Medical Oncologist and Clinical Researcher at the same Institute.

Between 1995 and 2003 he was Medical Director of the Cancer Prevention and Genetics Division of the European Institute of Oncology in Milan, Italy.

From 2004 to 2025 Dr De Censi was Director of the Medical Oncology Unit and the Department of Medicine and Geriatrics of the Galliera Hospital in Genoa.

In November 2025, he was appointed as Director of the Breast Unit at the Champalimaud Clinical Centre in Lisbon, Portugal.

In 2013, he received the National Scientific Qualification as University Full of Medical Oncology, and has been Honorary Professor at the Queen Mary University of London, UK.

Dr De Censi dedicated his career to cancer prevention and minimally toxic therapeutic strategies, with a lifelong focus on breast cancer. He has been principal investigator in more than 50 clinical trials and holder of a Master agreement with the US National Cancer Institute for phase I and II clinical trial in cancer prevention. He is the author of over 300 peer reviewed publications with a H-index of 59 and reviewer for the most important oncology journals.

• Pharmacoepidemiologist in the Real-World Evidence (RWE) workstream of EMA’s Data Analysis Task Force
• Before joining the EMA, worked in the pharmaceutical industry (pharmacovigilance) and academic research (pharmacoepidemiology).
• Licensed pharmacist and holds a MSc in public health epidemiology and a PhD is medical science / pharmacoepidemiology from Karolinska Institutet, Stockholm, Sweden.
• Methodological interest in causal inference and its application for regulatory decision making from observational (“real world”) data as well as from clinical trials
  • In relation to this, recent involvement in:
    • TARGET EU: Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks | HMA-EMA Catalogues of real-world data sources and studies
    • EMA/2020/46/TDA, Lot 3 – ROC36 Use of causal inference methods commonly used in non-interventional studies to estimate treatment effects in clinical trials | HMA-EMA Catalogues of real-world data sources and studies

Trained as an applied mathematician, Anna Malewski joined Fraunhofer SCAI in 2025 with the intention of contributing to relevant applications of AI and data science in biomedicine. The objective of her current research is to apply causal machine learning methods to support regulatory decision-making based on real-world data.

Dr. Leopold is an Assistant Professor of Drug Regulatory Science at the Division of Pharmacoepidemiology & Clinical Pharmacology at the Utrecht Institute for Pharmaceutical Science / WHO Collaborating Centre for Pharmaceutical Policy and Regulation. Her research focuses on evaluating pharmaceutical policies along the drug life cycle with the aim to improve affordable access to medicines. She has a particular interest in understanding European regulatory, HTA and pricing/funding processes within cancer care and for orphan medicinal products and uses various data sources (such as from registries, claims data from insurers, legal and policy documents as well as interview data) in her research.
From 2014 to 2018, Dr. Leopold was a Senior Research Fellow in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. Prior to that, she worked as a senior researcher at the Austrian Public Health Institute, Department of Health Economics / WHO Collaborating Center for Pharmaceutical Pricing and Reimbursement Policies, where she co-led the Austrian Centre for Rare Diseases as well as the European Network of public authorities of Pharmaceutical Pricing and Reimbursement Information (PPRI).
She holds a doctorate in Pharmaceutical Policy from Utrecht University, Utrecht Institute for Pharmaceutical Science / WHO Collaborating Centre for Pharmaceutical Policy and Regulation, a Master of International Health Care Management, Economics and Politics from Bocconi University (Italy) and a Master of International Business Relations from the University of Applied Science (Austria).

Dirk De Valck is a PhD in Molecular Biology. After having completed an academic career at different universities in Belgium, he decided to devote himself to patient advocacy with focus on addressing the unmet needs of people with ALS. Therefore, he joined the international non-profit organization EUpALS – The European Organization for Professionals and People with ALS. His responsibilities include close interaction with the EUpALS Patients and Carers Expert Board, providing advice in ALS clinical research from a patient perspective.

Diogo Almeida holds an MSc in Pharmaceutical Sciences from the Faculty of Pharmacy, University of Lisbon and is currently pursuing a PhD in Pharmaceutical Sciences at the same institution, specialising in pharmacoepidemiology. His research interests include the use of real-world data and patient experience data in regulatory and health technology assessment decision-making, work that he is developing through the EU-funded More-EUROPA consortium and in collaboration with the European Medicines Agency.

Prof. Dr. Holger Fröhlich holds a Diploma (with a specialization in Artificial Intelligence) and a PhD in Computer Science. After postdoctoral research at the German Cancer Research Center and a subsequent position as Senior Scientist at Cellzome AG (now part of GlaxoSmithKline), he was appointed Associate Professor at the University of Bonn in 2010.

In 2015, he joined the global biopharmaceutical company UCB, where he became Director of an AI and Data Science research team. From December 2019 to December 2025, he served as Head of the AI & Data Science Group and Deputy Head of the Department of Bioinformatics at the Fraunhofer Institute for Algorithms and Scientific Computing (SCAI) in Sankt Augustin. Since January 2026, he has been Head of the Department of Biomedical AI & Data Science at the same institute.

In parallel, he teaches as a Full Professor in the Master programs Life Science Informatics and Computer Science at the University of Bonn. Since October 2025, he has also been affiliated with the Institute for Digital Medicine at the University Hospital Bonn.

Holger Fröhlich’s focus is on the development and application of data science (specifically AI/ML) methods in biomedicine, with focus on target prioritization, precision medicine and clinical trials. In this context, Holger Fröhlich has developed over the last 20 years a broad spectrum of data science approaches, including techniques for multi-modal data integration, (generative) time series modeling, hybrid AI approaches (ODE/NN combinations, Graph Neural Networks) and causal machine learning. He is author and co-author of more than 190 scientific publications. He has been coordinator of three EU projects (JNPD ADIS, ERA PerMed DIGIPD, Marie-Sklodowska-Curie doctoral network AIPD), and partner in multiple further national and international research consortia as well as industry collaborations. Furthermore, he is scientific advisory board member of the international AI graduate school HIDSS4Health of the Helmholtz society.

Ivana Silva leads the EMA team responsible for activities related to the Agency’s engagement with patients, consumers, healthcare professionals and industry associations. She joined EMA in 2010 and has played a key role in developing and implementing stakeholder engagement practices across the Agency. Prior to joining EMA, she worked at the Pharmaceutical Group of the European Union (PGEU) and the Portuguese Pharmaceutical Society. Ivana holds a degree in Pharmaceutical Sciences from the University of Lisbon and an MBA in Information Management from the Portuguese Catholic University.

Kerstin Pfeifer is a Project Coordinator at BfArM with over five years of experience at the intersection of health policy, global health, and healthcare innovation. Prior to joining BfArM, she worked with GIZ and IOM in the field of international public health, supporting initiatives to strengthen vaccine access and manufacturing capacities globally. Holding a Master’s degree in Medical Science and Public Health from Lund University, she brings a broad international perspective to healthcare challenges. In her current role at BfArM, she coordinates the Real4Reg project, fosters successful collaboration among all project partners, and supports the development of Real4Reg’s training programme.

Mads Nielsen has and M.Sc. in Computer Science and Ph.D. in Image Analysis from University of Copenhagen. He has done research in the mathematical foundation of image analysis, computer vision, medical image analysis, and the foundation of quantitative imaging biomarkers and their use in epidemiology. He has published more than 300 research papers, graduated more than 45 Ph.D.s and is currently principal investigator on research grants for 100 MDKK+. Currently he is professor at Department of Computer Science, University of Copenhagen, Pioneer Centre for AI, and CEO and co-founder of Biomediq A/S, and co-founder of Aiomic, Cerebriu, Prenaital.

Márcia Silva has been Director of the Directorate for Medicines Risk Management (DGRM) at INFARMED since 2021. She graduated in Pharmaceutical Sciences from the Faculty of Pharmacy of the University of Coimbra in 1999. She worked in community pharmacy from 1999 and obtained the Specialist Qualification in Community Pharmacy in 2009. In 2014, she joined INFARMED, I.P. as a pharmacovigilance officer. Between 2016 and 2022, she was appointed as Portugal’s alternate representative on the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

Martin is a statistician by training and has been working at BfArM since 2023 as a doctoral researcher and scientist in the Real4Reg project. Prior to joining BfArM he spent a year as a trainee at the European Medicines Agency. His research interests lie in time-varying confounding and causal inference methods for observational studies.

Mohamed is a researcher and PhD candidate at Fraunhofer SCAI. His work focuses on biomedical data science and artificial intelligence, particularly in the context of complex and neurodegenerative diseases. He has worked with large-scale datasets such as UK Biobank and PPMI and is currently involved in the EU-funded Real4Reg project. Mohamed has a background in pharmacy and a master’s degree in Life Science Informatics from B-IT in Bonn.

Olga Kholmanskikh is a clinical assessor at the Belgian National Competent Authority, Federal Agency for Medicines and Health Products (FAMHP), since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences. She is a member of the EMA’s Oncology, Methodology and Scientific Advice Working Parties as well as an alternate member at the Committee for Advanced Therapies (CAT).

Paulo is 58 years old and has two extraordinary kids. He studied Applied Mathematics and Computational Sciences and worked in technology and business transformation consulting for about 30 years. Paulo was diagnosed with secondary progressive multiple sclerosis when he was forty and with two kids to raise, he started working on his recovery with one-hour sessions, three times a week, for more than 150 weeks. He walked again and the self-confidence allowed him to say in 2018 when he completed 50 years that “if his forties were his best decade so far, the fifties would be even better”. He just never imagined that it would be in patients with rare or chronic diseases advocacy.

He was the vice-president of the board of the Portuguese Society of Multiple Sclerosis for seven years. Paulo is now President of the General Assembly of SERaro.pt, President of the Fiscal Council of “Health in Dialogue Platform” and President of RD-Portugal (Union of Rare Disease Associations) since its foundation in May 2021, where around 50 rare diseases associations are gathered. He is a member of the experts group of the “More Data Better Health Program”, represents rare diseases in Portugal in the EURORDIS’ Council of National Alliances, is a member of the National Mirror Group to new European platform ERDERA (following EJPRD), represents people with rare diseases on PT_Med_Gen (the working group for the Portuguese National Strategy for Genomic Medicine), and represents RD-Portugal in the “Action Plan for Rare Diseases: From Strategy to Person 2025-2030”. Paulo is part of the Portuguese Order of Physicians Commission for Artificial Intelligence and he was nominated the Portuguese Order of Pharmacists Ombudsman for Service Recipients, in June 2024. He has a special interest in personal data security and in the safe utilisation of data to scientific progress, for the benefit of patients, but without neglecting health systems sustainability. 

Favourite book: “Start with why” by Simon Sinek

Favourite song: “Nothing’s gonna stop us now” by Starship”

Favourite value: Empathy

Rebecca has a MSc in Health Population and Society from the London School of Economics. She currently works at the European Institute of Women’s Health (EIWH) and manages various projects that promote safety of medicines in pregnancy, real-world data and AI, cervical cancer uptake among vulnerable women and digital health literacy. She represents EIWH and patients on many advisory groups, such as DG Sante HTA network or the ECDC Advisory Forum

Reimar is a consultant physician and professor of metabolic disease epidemiology at the Department of Clinical Epidemiology, Aarhus University & Aarhus University Hospital. He received his medical degree at Aarhus University in 1998 and defended his PhD in clinical epidemiology here in 2004. Currently he coordinates the metabolic disease epidemiology research program at their department at Aarhus University. He has ample experience with research project management and public-private collaboration projects with partners in the pharmaceutical industry. Reimar is a board member of the Danish Epidemiological Society, and advisor for the Danish Ministry of Health and the Danish Medicines Agency. His research activities are primarily focused on research based on clinical databases and registries and the primary fields of interest are pharmacoepidemiology and metabolic disease epidemiology, including complications of type 2 diabetes and obesity. Reimar has published about 375 papers in peer-reviewed scientific journals.

Saara is a Project Researcher at the School of Pharmacy, University of Eastern Finland. In the Real4Reg project, her responsibilities focus on UC3, the fluoroquinolone study, including the preparation of scientific manuscripts and training material. Her background is in clinical pharmacy, and prior to joining the Real4Reg team, she worked as a hospital pharmacist for two years.

Dr. Thuan Vo is a medical epidemiologist and researcher at the University of Eastern Finland. His research focuses on pharmacoepidemiology and the use of real-world data to evaluate the safety and effectiveness of medicines

Vera Ehrenstein is the scientific lead of Work Package 1 in Real4Reg. She is professor for phase IV studies at the Department of Clinical Epidemiology and Data Science, at Aarhus University, Denmark. She coordinates large multi-database studies on safety of medicines and vaccines, including regulator-mandated and industry-commissioned studies. Professor Ehrenstein has served on the Board of Directors of the International Society for Pharmacoepidemiology (ISPE) and is currently a member of the Steering Group of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP). In that capacity, she is continuously contributing to development of methodological guidelines, most recently, as the coordinating author of the guideline for conducting safety studies in pregnancy and breastfeeding using real-world data. She is the lead author of the ISPE-sponsored and endorsed guideline on validation of RWD-based algorithms and contributes to the RECORD-PE reporting guidelines.