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Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

机译：将监管机构的授权后措施与德国HTA机构的其他证据要求进行比较–联邦联合委员会的其他数据要求是否合理？

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摘要

ObjectivesThe aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency (EMA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA).

机译：目的本研究的目的是将欧洲药品管理局（EMA）的授权后措施（PAM）与德国联邦联合委员会（G-BA）进行的早期收益评估的固定条件有条件评估中的数据请求进行比较。

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期刊名称 Health Economics Review
作者
Jörg Ruof; Thomas Staab; Charalabos-Markos Dintsios; Jakob Schröter; Friedrich Wilhelm Schwartz;
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作者单位

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年(卷),期 2016(6),-1
年度 2016
页码 46
总页数 11
原文格式 PDF
正文语种
中图分类
关键词
Marketing authorisation Post-authorisation measure (Early) benefit assessment Conditional appraisal EMA G-BA;

机译：营销授权;授权后措施;（早期）收益评估;条件评估;EMA;G-BA;

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专利

1. Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified? [J] . J?rg Ruof, Thomas Staab, Charalabos-Markos Dintsios, Health Economics Review . 2016,第5期

机译：将监管机构的授权后措施与德国HTA机构的其他证据要求进行比较–联邦联合委员会的其他数据要求是否合理？
2. Opinion on the Draft decision of the German Federal Joint Committee on an Amendment to the early Cancer detection Guideline: Leaflet and Letter of Invitation with the Implementation of 630e BGB and the Right to object to the Invitations, Customization of Evaluation requirements and Data flows [J] . Wallwiener Diethelm, Beckmann Matthias W. Geburtshilfe und Frauenheilkunde . 2015,第6期

机译：关于德国联邦联合委员会关于早期癌症检测指南修正案的决定草案的意见：实施630e BGB的传单和邀请函以及反对邀请，评估要求和数据流定制的权利
3. Comparison of additional regulatory requirements for conducting clinical trials on genetically-modified micro-organisms and recombinant DNA in Europe, the United States, and Canada [J] . Lee KC Drug information journal . 2002,第2期

机译：对欧洲，美国和加拿大进行遗传修饰的微生物和重组DNA进行临床试验的额外监管要求的比较
4. Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree [O] . C. M. Dintsios, F. Worm, J. Ruof, 2019

机译：委托的HTA机构和德国的委托决策者对HTA的其他证据的不同解释：每当IQWiG和联邦联合委员会不同意时
5. Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified? [O] . 2016

机译：将监管机构的授权后措施与德国HTA机构的其他证据要求进行比较–联邦联合委员会的其他数据要求是否合理？

Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

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