WebJun 16, 2016 · ICH GCP; US Clinical Trials Registry; Clinical Trial NCT02810743; Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer (Subito) ... intensified alkylating 'mini' CTC (2x) cyclophosphamide 3000 mg/m2 day 1 mesna 500 mg (push) + 2000 mg in 24 hours day 1 carboplatin (400 mg/m2; (or AUC=5 in patients with … WebDas seit 2011 bestehende Center for Translational & Clinical Research Aachen (CTC-A) ... Umfassende Kenntnisse in der Durchführung von Klinischen Prüfungen nach ICH-GCP und den geltenden regulatorischen Anforderungen (sowohl für Studien nach dem Arzneimittel- als auch Medizinprodukterecht-Durchführungsgesetz) durch mehrjährige ...
Monitor/Projektmanager/-in (w/m/d) im Bereich klinischer Studien
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Clinical Trial on CKD 5D, Hemodialysis: daily supplementation of …
WebHere is a list of regulatory guidances to help you understand the regulatory requirements for conducting clinical trials. Conduct of clinical trials during COVID-19. Clinical trial submissions. Conducting clinical trials. Good Clinical Practice. Investigational product. Adopted guidelines. Other guidelines. WebApr 16, 2024 · For this reason, the GLP regulations, GCP guidelines, and GMP guidelines must be followed. Good Laboratory Practice (GLP) regulates the processes and conditions under which clinical and non-clinical research is conducted. GLP also governs how these research facilities should be maintained. Good Clinical Practice (GCP) guidelines are … WebUpdated jan 2024. This GCP training course is a step-by-step and up-to-date guide to the international ICH-GCP (E6-R2) guidelines. It is essential for anyone taking part in the running of a clinical trial. The course was written by an expert with over 30 years' experience up to Research Director level in a major pharma group. grand county heating and cooling