Safety Reporting for Auxiliary Medicinal Products in the Sibeprenlimab Phase-III Study According to the New European Union (536/2014) CT Regulation.
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DOI: 10.2174/0115748863329287250411114336
Abstract: BACKGROUND The new European Union clinical trials regulation (EU CTR 536/2014) became effective on 31 January 2022. It introduced the novel concept of Auxiliary Medicinal Products (AxMPs) to be implemented in clinical trials in Europe.… read more here.
Keywords: auxiliary medicinal; european union; 536 2014; safety ... See more keywords
How Regulation 536/2014 Is Changing Academic Research with Therapeutic Radiopharmaceuticals: A Local Experience
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DOI: 10.3390/ph18111709
Abstract: Background/Objectives: This report examines the future of academic studies involving investigational therapeutic radiopharmaceuticals within the framework of Regulation (EU) No. 536/2014. It discusses the impact of Good Manufacturing Practice (GMP) requirements (EudraLex-Volume 4-Good Manufacturing Practice… read more here.
Keywords: local experience; therapeutic radiopharmaceuticals; 536 2014; research ... See more keywords