Book 1C-FDAE6R3: 2025 Good Clinical Practice Regulations in the US & the EU (With FDA/ICH GCP E6(R3))Description Contents Cover This spiral bound, 5" x 7. 5" book consists of US FDA GCP regulations, including all of 21 CFR Part 314 (NDAs), ICH Guidelines, the new EU Clinical Trials Regulation, as well as the EU GCP Directive and the repealed EU Clinical Trials Directive. Who Uses this Book and How? Clinical Research staff, as job aids Training departments, as training handouts Human Resources, as part of new employee orientation Legal Regulatory QA