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

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.

• 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

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.

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.

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).

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).

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.

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.

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.

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.