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EU CTR – CTIS: Public Portal Analysis under revised Transparency Rules

2024 . Vollmer, Ulrike | Matuschek, Iris Romero

Nutzung von Registerdaten für regulatorische Entscheidungsfindung

2023 . Pflanz, Nerina | Seemann-Roch, Wiebke | Bergner, Simone

Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments

2023 . Müller, Svenja | Zeidler, Claudia | Ständer, Sonja

Umgang mit vertraulichen Daten für CTIS – Blick auf einen EMA Leitlinien-Entwurf

2023 . Yazdanparast, Haniyeh

Treatment of Patients with Multiple Sclerosis Transitioning Between Relapsing and Progressive Disease

2023 . Dimitriou, Nikolaos G. | Meuth, Sven G. | Martinez-Lapiscina, Elena H. | Albrecht, Philipp | Menge, Til

Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST

2023 . Nobbs, David | Piwko, Wojciech | Bull, Christopher | Cormack, Francesca | Ahmaniemi, Teemu | Holst, Sebastian C. | Chatterjee, Meenakshi | Maetzler, Walter | Avey, Stefan | Ng, Wan Fai

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

2023 . Kirsch-Stefan, Nadine | Guillen, Elena | Ekman, Niklas | Barry, Sean | Knippel, Verena | Killalea, Sheila | Weise, Martina | Wolff-Holz, Elena

Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

2023 . Manolis, Efthymios | García Arieta, Alfredo | Lindahl, Anders | Kotzagiorgis, Evangelos | Limberg, Jobst | Holte, Øyvind | Paixao, Paulo | Versantvoort, Carolien | Tshinanu, Flora Musuamba | Blake, Kevin | Van Den Heuvel, Michiel

Molecular diagnostics and therapies for gastrointestinal tumors: a real-world experience

2021 . Welland, Sabrina | deCastro, Tiago | Bathon, Melanie | Wirth, Thomas Christian | Reineke-Plaaß, Tanja | Saborowski, Michael | Lehmann, Ulrich | Saborowski, Anna | Vogel, Arndt

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