GCP - Good Clinical Practice Handbooks
Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook |
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
Updated 2024 - 21 CFR 312, 314, 511 - Human and Animal Drug Approval |
Updated 2024 - 21 CFR 50 - Protection of Human Subjects |
21 CFR 54 - Financial Disclosure by Clinical Investigators |
21 CFR 56 - Institutional Review Boards |
Eudralex - Pharmacovigilance for Medical Products Volume 9a |
Updated 2024 - 21 CFR 312 - Investigational New Drug Application |
21 CFR 314 - Applications for FDA Approval to Market a New Drug |
21 CFR 316 - Orphan Drugs |
Clinical Master Reference Guide |
Electronic Systems Master Handbook 1 |
21 CFR 320 - Bioavailability and Bioequivalence Requirements |
VICH GL9 Animal GCP |
Dietary Supplement Master Handbook |
ICH Q2(R2) and ICH Q14 Analytical Validation |
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs |
GMP Manufacturing Handbook |
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14 |
Title 21 CFR Parts 1 - End Nine Volume Set |
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