Pages that link to "Glossary:TAG-00328-Com-egu"
From GxPlex
The following pages link to Glossary:TAG-00328-Com-egu:
Displaying 21 items.
- Glossary (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 (â links)
- Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart E (â links)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) (â links)
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.530 (â links)
- Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 - (â links)