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Certificazione CRA

A Clinical Research Associate (CRA) 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 (CRO). UN Leggi tutto…

Revisore dei conti, GCP

Revisore dei conti, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “Buona pratica clinica: Linee guida consolidate,” (GCP), Supportare un programma di garanzia della qualità (QA) per garantire che i dati del progetto AGN e le dichiarazioni di riepilogo siano di qualità nota e documentata. Riepilogo delle responsabilità: Leggi tutto…

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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: Linee guida consolidate,” (GCP/GLP’s), Supportare un programma di garanzia della qualità (QA) to ensure that Allergan project data and summary statements are of known and documented Leggi tutto…

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Top Contract research organisations (CROs) . Listing

Phoenix Clinical Research Berytech Technology & Health Damascus Road, Beirut-Lebanon mobile : + 961 3 672 310 (Dr. Georges Labaki) office number: + 961 1 429 566 [email protected] website – https://www.phoenix-cr.com/ _______________________ Contract research organisations (CROs) by Peter Hogg ProClinical Life Sciences have become essential to the pharma, biotech, and medtech Leggi tutto…

ТРЕНИНГ: Организация клинических исследований и сертификация специалиста по проведению КИ

Организация клинических исследований и сертификация специалиста по проведению КИМодуль 1. Введение в клинические исследования (Quello) История и развитие клинических исследованийОсновные понятия и терминологияТипы и фазы клинических исследований (Phase I-IV)Международные и локальные регуляторные требования (Ich-GCP, FDA, EMA )Модуль 2. Этические аспекты КИ Принципы биоэтики и этические комитетыДекларация ХельсинкиПроцедура получения информированного согласия Leggi tutto…