User contributions for Gxplex admin

29 June 2026

• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) II 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) I 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EUR European Bioethics Convention 1997 - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:INT Nuremberg Code 1947 Code 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:GBR MHRA GCP Inspection Dossier template V7.0 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:DEU Deutsches Ärzteblatt 45849 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Document:WMA Declaration of Helsinki 2024 1 revision imported