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TITLE: Clinical Evidence 2030
AUTHORS: Arlett, Peter; Umuhire, Denise; Verpillat, Patrice; Foggi, Paolo; Liminga, Ulla Waendel; Sepodes, Bruno; Lunzer, Marianne; Aylward, Brian; Vamvakas, Spiros; Roes, Kit; Petavy, Frank; Thirstrup, Steffen; Lamas, Maria; Cooke, Emer; Broich, Karl;
PUBLISHED: 2025, SOURCE: CLINICAL PHARMACOLOGY & THERAPEUTICS
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
2
TITLE: Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey  Full Text
AUTHORS: Windfuhr, Fabian; de Vries, Sieta T.; Melinder, Maria; Dahlqvist, Tanja; Almeida, Diogo; Sepodes, Bruno; Torre, Carla; Wettermark, Bjoern; Mol, Peter G. M.;
PUBLISHED: 2025, SOURCE: DRUG SAFETY
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
3
TITLE: Review of studies evaluating the effectiveness of risk minimization measures for oncology medicinal products registered in the European Medicines Agency (HMA-EMA) catalogue: findings and lessons learned
AUTHORS: Monteiro, Jorge; Almeida, Diogo; Fernandes, Joao Paulo; Sepodes, Bruno; Torre, Carla;
PUBLISHED: 2025, SOURCE: EXPERT OPINION ON DRUG SAFETY
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
4
TITLE: European Medicines Agency approvals of new medicines in March and April 2025
AUTHORS: Sepodes, Bruno; Burgos, Juan Garcia; Thirstrup, Steffen;
PUBLISHED: 2025, SOURCE: LANCET REGIONAL HEALTH-EUROPE, VOLUME: 54
INDEXED IN: WOS CrossRef
IN MY: ORCID
5
TITLE: Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop
AUTHORS: Plueschke, Kelly; Jonker, Carla; Kankanen, Hanna; Vetter, Thorsten; Sepodes, Bruno; Naehrlich, Lutz; Hillert, Jan; Crane, Gracy; Straus, Sabine; Foggi, Paolo; Martin, Simona; Kyriakopoulou, Christina; Mol, Peter; Day, Francesca; Breen, Kieran; Bennett, Neil; de Lemus Belmonte, Mencia; Bennett, Simon; Verpillat, Patrice; Roes, Kit C. B.; Cochino, Ana; Schaefer, Franz; Hernandez Rivas, Jesus Maria; McGettigan, Patricia; Arlett, Peter; ...More
PUBLISHED: 2025, SOURCE: CLINICAL PHARMACOLOGY & THERAPEUTICS
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
6
TITLE: Thirty years of Europe’s centralized procedure for approving medicines
AUTHORS: Emer Cooke; Bruno Sepodes;
PUBLISHED: 2025, SOURCE: Nature Medicine
INDEXED IN: CrossRef
IN MY: ORCID
7
TITLE: Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024  Full Text
AUTHORS: Almeida, Diogo; Mandslay, Diana; Mol, Peter G. M.; Sepodes, Bruno; Torre, Carla;
PUBLISHED: 2025, SOURCE: BIODRUGS
INDEXED IN: Scopus WOS CrossRef
IN MY: ORCID
8
TITLE: European medicines agency approvals of new medicines in July and August 2025
AUTHORS: Bruno Sepodes; Juan Garcia Burgos; Steffen Thirstrup;
PUBLISHED: 2025, SOURCE: The Lancet Regional Health - Europe, VOLUME: 57
INDEXED IN: CrossRef
IN MY: ORCID
9
TITLE: The European Medicines Agency's review of Kaftrio (elexacaftor–tezacaftor–ivacaftor): extending its use to all people with CF aged 2 years and older who do not have two class I CFTR variants  Full Text
AUTHORS: Catherine Drai; Hanneke J van der Woude; Anne J Lexmond; Tineke van den Hoorn; Peter G.M Mol; Finbarr P Leacy; Agnieszka Przybyszewska; Bruno Sepodes; Thomas Castelnovo;
PUBLISHED: 2025, SOURCE: European Respiratory Journal
INDEXED IN: CrossRef
IN MY: ORCID
10
TITLE: Trends in orphan medicinal products approvals in the European Union between 2010–2022  Full Text
AUTHORS: Luísa Bouwman; Bruno Sepodes; Hubert Leufkens; Carla Torre;
PUBLISHED: 2024, SOURCE: Orphanet Journal of Rare Diseases, VOLUME: 19, ISSUE: 1
INDEXED IN: Scopus CrossRef
IN MY: ORCID
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