The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
Origin/Publisher:
Europäische Kommision, Brüssel
Document Type:
Guideline
Content:
clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and administration procedures, traceability, retention of samples, protection of trial subjects, safety reporting and monitoring
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