Papers matching “regulatory requirements” 513
Not finding it? Sign in to also search OpenAlex live.
-
Operationalising ICT Requirements from NIS2, DORA and the AI Act through Enterprise Architecture Models for Information Systems Modernisation2026 Zenodo (CERN European Organization for Nuclear Research) article Business, Management and Accounting Information Technology Governance and Strategy Open access
Beāte Krauze, Ada Slupczynski, Simon Hacks, Philipp-Lorenz Glaser, Dominik Bork
0citations -
Operationalising ICT Requirements from NIS2, DORA and the AI Act through Enterprise Architecture Models for Information Systems Modernisation2026 Zenodo (CERN European Organization for Nuclear Research) article Business, Management and Accounting Information Technology Governance and Strategy Open access
Beāte Krauze, Ada Slupczynski, Simon Hacks, Philipp-Lorenz Glaser, Dominik Bork
0citations -
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions2025 Drug Safety article Pharmacology, Toxicology and Pharmaceutics Pharmacovigilance and Adverse Drug Reactions Open access
Jami Peters, Ayad K. Ali, Maria Moitinho de Almeida, Keiko Asao, Tarek A. Hammad, Xintong He, +5 more
0citations -
Multi-Agent LLM Workflow for Regulatory-Driven Requirement Generation in Automotive Software Development2026 SAE technical papers on CD-ROM/SAE technical paper series conference-paper Engineering Safety Systems Engineering in Autonomy
Abdelrahman Said Abdalla, Lukas Schäfers, Fabian Schmidt, Joschka Schaub, Sung-Yong Lee, Jakob Andert
0citations -
D2.1 Requirements on an IoT Cloud/Edge System for the Energy Ecosystem2024 Zenodo (CERN European Organization for Nuclear Research) article Engineering Smart Grid Energy Management Open access
RWTH Aachen University, Katharina Aurelia Wehrmeister, Marjorie Hoegen, Luigi Briguglio, Christina Sianidou
0citations -
D2.1 Requirements on an IoT Cloud/Edge System for the Energy Ecosystem2024 Zenodo (CERN European Organization for Nuclear Research) article Engineering Smart Grid Energy Management Open access
RWTH Aachen University, Katharina Aurelia Wehrmeister, Marjorie Hoegen, Luigi Briguglio, Christina Sianidou
0citations -
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation2023 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, +10 more
46citations -
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL2024 Clinical Pharmacology & Therapeutics article Mathematics Statistical Methods in Clinical Trials Open access
Katharina Hees, Sabina Hernandez Penna, Franz König, Martin Posch, Marta Bofill Roig, Elias Laurin Meyer, +11 more
17citations -
Conformity Between Values and EU Legal Requirements Regarding an AI Clinical Decision Support System (AI-CDSS) for Improved Cardiovascular Risk Management (DECIDE)2025 SSRN Electronic Journal preprint Social Sciences Digitalization, Law, and Regulation Open access
María José Villalobos-Quesada, de Graaf, André Krom, Sara Colombo, Myrthe L. van de Pavert, Maaike Harbers, +4 more
2citations -
Attempts to align research in thrombosis and hemostasis with the In Vitro Diagnostic Medical Device Regulation (IVDR, European Union) requirements2025 Journal of Thrombosis and Haemostasis article Immunology and Microbiology Complement system in diseases Open access
François Mullier, Piet Meijer, Christa M. Cobbaert, Dominique Lasne
1citations -
Supporting Requirements Assessment Through Enterprise Architecture Models2026 Zenodo (CERN European Organization for Nuclear Research) other Business, Management and Accounting Information Technology Governance and Strategy Open access
Beāte Krauze, Ada Slupczynski, Simon Hacks, Philipp-Lorenz Glaser, Dominik Bork
0citations -
Comprehensive Mapping of Key Regulatory Networks that Drive Oncogene Expression2020 Cell Reports article Biochemistry, Genetics and Molecular Biology Genomics and Chromatin Dynamics Open access
Lin Lin, Benjamin R. Holmes, Max W. Shen, Darnell Kammeron, Niels Geijsen, David Kenneth Gifford, +1 more
18citations -
Zinc deficiency impairs the development of human regulatory B cells from purified B cells2024 Journal of Trace Elements in Medicine and Biology article Immunology and Microbiology T-cell and B-cell Immunology Open access
Mary-Ann Puppa, Sabrina Bianca Bennstein, Henrike Josephine Fischer, Lothar Rink
6citations -
Empowering regulatory science for medical devices in Europe2026 The Lancet Regional Health - Europe article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Robert A. Byrne, Elisabeth M. C. Dequeker, Per Kjærsgaard‐Andersen, Sanja Kolaček, Tom Melvin (16298975), +3 more
0citations -
Advancing regulatory dialogue: In silico models for improved vaccine biomanufacturing - an expert meeting report2025 Vaccine article Biochemistry, Genetics and Molecular Biology Viral Infectious Diseases and Gene Expression in Insects Open access
Irina Meln, Wim Van Molle, Mónica Vélez, Greger Abrahamsen, Koen Brusselmans, Éric Calvosa, +19 more
6citations -
Trsp is required by regulatory T cells to prevent lethal autoimmunity in mice2025 bioRxiv (Cold Spring Harbor Laboratory) preprint Immunology and Microbiology T-cell and B-cell Immunology Open access
Justin Jacobse, Jennifer M. Pilat, Aaron Kwag, Zaryab Aziz, Channing Chi, M. Diana Neely, +13 more
0citations