User contributions for Gxplex admin

29 June 2026

• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU MDCG Guidelines - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EudraLex – Volume 10 - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU EMA Guidelines - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU CHMP Guidelines - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU 2011/C 172/01 - CT-3 11-Jun-2011 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT Question - BASG 11-Feb-2025 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT MPG – Medizinproduktegesetz 26-May-2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT FAQ - COVID-19 Studien 15-Mar-2021 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:AUT BASG - FAQ 11-Feb-2025 1 revision imported