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Property:RefLanguage

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Showing 20 pages using this property.
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USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) +
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USA 21 CFR Part 312 09-Apr-2025 § 312.56 +
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USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) +
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USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) +
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USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 +
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USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 +
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ICH ICH E8 Guideline R1 (2021) 4.3.3.1 +
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ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 +
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EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 +
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EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 +
EN  +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2 +
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ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002 +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) +
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EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76 +
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EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 65 +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16. +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 3 +
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GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2 +
EN  +
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