Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products

Title:
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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