乌克兰的干细胞治疗

颁发 GCP 证书的测试任务示例 2020-2021 年

颁发 GCP 证书的测试任务示例 2020-2021 年 1) 在生物等效性研究中使用交叉设计时:   A) 组中的患者接受相同的治疗.   乙) 患者, 使用随机化程序, распределяются на две или больше групп, а пациентам группы назначается разное лечение.   c) 患者, при помощи 阅读更多…

乌克兰的干细胞治疗

良好临床实践

良好临床实践

描述: 

The tripartite harmonised ICH Guideline was finalised underStep 4 在五月 1996. 本良好临床实践文件描述了所有参与者在进行临床试验中的责任和期望, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator’s Brochure which had been agreed earlier through the ICH process.

Implementation

Step 5

欧洲联盟:

Adopted by CPMP, 七月 1996, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97

MHLW:

Adopted March 1997, PAB Notification No. 430, MHLW Ordinance No. 28

美国食品药品监督管理局:

Published in the Federal Register, 9 可能 1997, Vol. 62, No. 90, p. 25691-25709

乌克兰的干细胞治疗

Top Contract research organisations (合同研究组织) . 清单

Phoenix Clinical Research Berytech Technology & Health Damascus Road, Beirut-Lebanon mobile : + 961 3 672 310 (博士. 乔治·拉巴基) 办公室号码: + 961 1 429 566 info@phoenix-cr.com website – https://www.phoenix-cr.com/ _______________________ Contract research organisations (合同研究组织) by Peter Hogg ProClinical Life Sciences have become essential to the pharma, biotech, and medtech 阅读更多…

乌克兰的干细胞治疗

CRA certification

A Clinical Research Associate (加拿大税务局) is a profession defined by Good clinical practice guidelines (ICH GCP). The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (合同研究组织). A 阅读更多…

乌克兰的干细胞治疗

Director, GCP

Responsibilities The Director, GCP will be required to oversee all and participate in, quality assurance auditing of all activities subject to the, “ICH Good Clinical/Laboratory Practice: 综合指南,” (GCP/GLP’s), 支持质量保证计划 (质量保证) to ensure that Allergan project data and summary statements are of known and documented 阅读更多…

干细胞疗法