日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

The European Medicines Agency's review of elexacaftor/tezacaftor/ivacaftor: extending its use to all people with cystic fibrosis aged 2 years and older who do not have two class I CFTR variants

欧洲药品管理局对 elexacaftor/tezacaftor/ivacaftor 的审查:将其使用范围扩大到所有 2 岁及以上、不携带两个 I 类 CFTR 变异体的囊性纤维化患者。

Drai, Catherine; van der Woude, Hanneke J; Lexmond, Anne J; van den Hoorn, Tineke; Mol, Peter G M; Leacy, Finbarr P; Przybyszewska, Agnieszka; Sepodes, Bruno; Castelnovo, Thomas

Balancing benefit and risk in early Alzheimer's disease: the European Medicines Agency (EMA) assessment of lecanemab and donanemab

平衡早期阿尔茨海默病治疗的获益与风险:欧洲药品管理局 (EMA) 对 lecanemab 和 donanemab 的评估

Guizzaro, Lorenzo; Bałkowiec-Iskra, Ewa; Haberkamp, Marion; Mol, Peter G M; Moreau, Alexandre; Mueller-Berghaus, Jan; Philadelphy, Daniela; Balabanov, Pavel; Garcia, Juan; Thirstrup, Steffen; Sepodes, Bruno

The European medicines agency review of belzutifan (Welireg) for the treatment of adult patients with von Hippel-Lindau disease-associated tumors

欧洲药品管理局对用于治疗成人von Hippel-Lindau病相关肿瘤的belzutifan(Welireg)的审查

Baron, Antonella; Broekman, Esther; van Gils, Martijn; Poplavska, Elita; Mol, Peter; Saliete, Ieva; Sepodes, Bruno; Pean, Elias

Safety population size and duration of exposure prior to approval of new medicines: A database analysis of medicines centralised approved in the European Union between 2011 and 2023

新药获批前的安全人群规模和暴露持续时间:基于2011年至2023年间欧盟集中批准的药品数据库分析

Bouwman, Luísa; Leufkens, Hubert; Sepodes, Bruno; Torre, Carla

A Cross-Sectional Survey of Evidence Needs for Medicinal Products in Europe With a Focus on Real-World Evidence

欧洲药品证据需求横断面调查——以真实世界证据为重点

Melinder, Maria; Windfuhr, Fabian; Dahlqvist, Tanja; Torre, Carla; Sepodes, Bruno; Mol, Peter G M; Almeida, Diogo; Ekheden, Isabella; Feltelius, Nils; Roes, Kit; de Vries, Sieta T; Wettermark, Björn

Three decades of clinical trials in Portuguese-speaking Africa: a comprehensive scoping review protocol

葡语非洲地区三十年的临床试验:一项全面的范围界定审查方案

Batista, Jorge Pedro Barroso; Teixeira, Maria Manuel; Torre, Carla de Matos; Sepodes, Bruno; Abecasis, Ana; Mota-Filipe, Helder

European Medicines Agency approvals of new medicines in September and October 2025

欧洲药品管理局2025年9月和10月批准的新药数量

Sepodes, Bruno; Burgos, Juan Garcia; Thirstrup, Steffen

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

上市后措施中纳入真实世界数据:以2013年至2024年欧盟获批的先进疗法药品为例

Almeida, Diogo; Mandslay, Diana; Mol, Peter G M; Sepodes, Bruno; Torre, Carla

Clinical Evidence 2030

临床证据2030

Arlett, Peter; Umuhire, Denise; Verpillat, Patrice; Foggi, Paolo; Wändel Liminga, Ulla; Sepodes, Bruno; Lunzer, Marianne; Aylward, Brian; Vamvakas, Spiros; Roes, Kit; Pétavy, Frank; Thirstrup, Steffen; Lamas, Maria; Cooke, Emer; Broich, Karl

Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop

优化患者登记系统以辅助监管决策——HMA/EMA多方利益相关者研讨会的主要经验总结

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; Hernández-Rivas, Jesús María; McGettigan, Patricia; Arlett, Peter