User contributions for Gxplex admin

29 June 2026

• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT Ärztegesetz 08-Mar-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT AMG – Arzneimittelgesetz 04-Mar-2023 1 revision imported
• 15:0015:00, 29 June 2026 diff hist +2,282 N In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 style: remove width:100% from wikitable current
• 15:0015:00, 29 June 2026 diff hist +2,240 N TestPage MDR style: remove width:100% from wikitable current
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR MHRA GCP Inspection Dossier template V7.0 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU Deutsches Ärzteblatt 45849 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference: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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 10 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 8.4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 16 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.17 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 36 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.54 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.40 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR HRA - Ending your project 28-Jan-2025 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NIS 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3. 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report 1 revision imported