清晰地讲述了TPP与CDP的概念与关系:TPP“Target Product Profile”,翻译成中文就是目标产品概况,TPP问的是“What?”;CDP“Clinical Development Plan”,指临床开发计划,是描述一个候选药物如何从首次在人体上试用到上市注册(甚至上市后)的蓝图,CDP需要...
CE认证、第四版临床评估报告编写、MDR文件编写、MDR转版咨询、欧盟代表服务 欧盟医疗器械法规MDR施行在即,然而许多小伙伴还对法规不太了解,今天就要和大家谈谈MDR中的CDP(clinical Development plan)和临床证据的要求到底是什么? CDP是在MDR附录XIV中的...
CDP在医学上指的是**临床开发计划(Clinical Development Plan),它是新药开发过程中的重要文件,用于指导药物从临床试验到上市注册的整个过程。CDP的制定有助于系统考量科学、商业、临床研究设计、监管部门的要求,以及决策节点的选择及决策标准等,从而提高决策的科学性。CDP在医学上的具体应用: 临床开发计划(CDP)的定义和...
吕玉真老师为同学们讲解了法规事务在TPP和CDP制订中的角色,介绍了欧美日及中国的法规要求和注册通道,并重点强调了与FDA、EMA会议类型及需要注意的问题。吕老师结合实际申报经历,进一步诠释了注册策略开发计划(RSDP,regulatory strategy development plan)及其与CDP和TPP的关系,深化了大家对临床研究不同阶段和情况下注册策略...
To access PMI’s latest reports such as PMI’sTCFD Report 2022,PMI’s Low-Carbon Transition Plan,PMI’s Water & Biodiversity Ambitions 2022, as well as additional information on its approach to sustainability, please visitpmi.com/sustainability. ...
finalising the trial financing plan. We have selected this population because it has a high unmet need, represents a significant commercial opportunity, patients are readily identifiable, and the clinical path is clear. We look forward to communicating the trial design and associated financing plan. ...
RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Compan...
competition / kRmpE5tiFEn/ 竞争 competitive / kEm5petitiv/ 竞争的 consumption / kEn5sQmpFEn/ 消费 demand / di5ma:nd/ 需求 outlet / 5aut-let/ 销路 offer / 5RfE/ 报盘,发价 monopoly / mE5nRpEli/ 垄断 forecast / 5fR:ka:st/ 预测 budget / 5bQdVit/ 预算 plan / plAn/ 计划 estimate...
To access PMI’s latest reports such as PMI’sTCFD Report 2022,PMI’s Low-Carbon Transition Plan,PMI’s Water & Biodiversity Ambitions 2022, as well as additional information on its approach to sustainability, please visitpmi.com/sustainability. ...