Pages that link to "Glossary:TAG-00041-Ame-run"
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The following pages link to Glossary:TAG-00041-Ame-run:
Displaying 32 items.
- Glossary (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-001 (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) (â links)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1 (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 (â links)
- Reference:DEU KPBV - Klinische PrĂźfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 (â links)
- Reference:DEU MPDG - Medizinprodukterecht-DurchfĂźhrungsgesetz 28-Jun-2022 § 54 (â links)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 (â links)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 (â links)
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8 (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5) (â links)
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.526 (â links)