Terapia con células madre

Надлежащая производственная практика (cGMP)

Надлежащая производственная практика (cGMP) Целевая аудитория Курс предназначен для всех ученых (управленческий и лаборатории) и профессионалов в области биотехнологий, биофармацевтической, устройство, косметической, фармацевтической промышленности и агрохимикатов, чья работа функции, связанные с наркотиками / биологических Lee mas…

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Auditor GCP

Auditor, GCP

Auditor, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “Buenas Prácticas Clínicas de la ICH: Directriz consolidada,” (GCP), apoyar un programa de aseguramiento de la calidad (QA) to ensure that Lee mas…

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anesthesia conferences

Medical meetings in Ukraine

Today we have analyzed the popularity of medical conferences in Ukraine. sí, may be it’s not such popular conferences, but level of training of lecturers and level of knowledge gained at conferences in Kiev is very high. Also interested in the existence of various social programs organized by the company NBScience (interview with Lee mas…

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investigación clínica

Buena práctica clínica

Buena práctica clínica

Descripción: 
The tripartite harmonised ICH Guideline was finalised underStep 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, 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
EU:
Adopted by CPMP, julio 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
FDA:
Published in the Federal Register, 9 Mayo 1997, Vol.. 62, No. 90, p. 25691-25709
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terapia con células madre