在开始之前,详细了解适用于循环肿瘤细胞分析仪的相关法规和监管指南。针对美国的FDA,您需要关注《医疗器械修正法案》(Medical Device Amendments,MDA)和《医疗器械分类法案》(Medical Device Classification Act,MDCR)。欧洲的EMA则可能会涉及《医疗器械法规》(Medical Device Regulation,MDR)。 2. 制定研究计划和设计: 制...
培训讲师介绍 Mr. Matthew Azuh is the Founder and CEO of Global PharmaDevice Solutions (GPDS) located in Chicago Area, IL USA. GPDS is a global regulatory consulting firm and product sterility testing laboratory serving the pharmace...
培训讲师介绍 Mr. Matthew Azuh is the Founder and CEO of Global PharmaDevice Solutions (GPDS) located in Chicago Area, IL USA. GPDS is a global regulatory consulting firm and product sterility testing laboratory serving the pharmaceutical, biologics, and medical device industry across the globe. M...
欧盟EMA于2012年7月提出.pdf,當代醫藥法規月刊 第 083 期 出版日期:2017 年9月 8日 國際醫藥法規新知 簡介 次世代定序技術及美國的法規管理 p. 1-12 我國藥品法規科學諮詢之創新方案 p. 13-26 國際醫藥聞新知 歐盟 EMA 於2017 年3月發表 「製藥用水品質指引
(EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice...
Microsatellite instability (MSI) is a prognostic marker in colorectal cancer (CRC). The biological significance of MSI-low (MSI-L) phenotype and its differences with microsatellite stable (MSS) phenotype remains unclear. The aim of this study is indicati