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List of results
- Document:GBR MHRA GCP Inspection Dossier template V7.0 + (Information from official body)
- Document:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 + (Information from official body)
- 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 + (Information from official body)
- Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 + (International guideline)
- Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 + (International guideline)
- Document:ICH ICH E11 Guideline R1 (2017) + (International guideline)
- Document:ICH ICH E19 Guideline 2022 + (International guideline)
- Document:ICH ICH E21 Concept paper 2023 + (International guideline)
- Document:ICH ICH E2A Guideline 1994 + (International guideline)
- Document:ICH ICH E2F Guideline 2010 + (International guideline)
- Document:ICH ICH E3 Guideline 1995 + (International guideline)
- Document:ICH ICH E6 Guideline R3 (2025) + (International guideline)
- Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 + (International guideline)
- Document:ICH ICH E7 Guideline 1993 + (International guideline)
- Document:ICH ICH E8 Guideline R1 (2021) + (International guideline)
- Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 + (International guideline)
- Document:ICH ICH E9 Guideline 1998 + (International guideline)
- Document:INT ISPE - GPP Revision 3 (2015) + (International guideline)
- Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 + (International guideline)
- Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 + (International guideline)
- Document:WHO WHO - Guidance for best practices for clinical trials 2024 + (International guideline)
- Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 + (International guideline)
- Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 + (International guideline)
- Document:WHO WHO - ICD 11 + (International guideline)
- Document:WMA Declaration of Helsinki 2024 + (International guideline)
- Document:EUR European Bioethics Convention 1997 + (International treaty)
- Document:INT Nuremberg Code 1947 + (Jurisprudence)
- Document:AUT AMG – Arzneimittelgesetz 04-Mar-2023 + (Legal act)
- Document:AUT Ärztegesetz 08-Mar-2023 + (Legal act)
- Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021 + (Legal act)
- Document:AUT MPG – Medizinproduktegesetz 26-May-2022 + (Legal act)
- Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023 + (Legal act)
- Document:DEU BGB - BĂĽrgerliches Gesetzbuch 22-Dec-2023 + (Legal act)
- Document:DEU MPDG - Medizinprodukterecht-DurchfĂĽhrungsgesetz 28-Jun-2022 + (Legal act)
- Document:DEU SGB V - Sozialgesetzbuch FĂĽnftes Buch 20-Dez-1988 + (Legal act)
- Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 + (Legal act)
- Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 + (Legal act)
- Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 + (Legal act)
- Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 + (Legal act)
- Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 + (Legal act)
- Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 + (Legal act)
- Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 + (Legal act)
- Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 + (Legal act)
- Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 + (Legal act)
- Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 + (Legal act)
- Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 + (Legal act)
- Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 + (Legal act)
- Document:FRA Constitution du 4 octobre 1958 10-Mar-2024 + (Legal act)
- Document:GBR Data Protection Act 2018 06-Jun-2022 + (Legal act)
- Document:GBR Directive 2001/20/EC 04-Apr-2001 + (Legal act)
- Document:GBR Directive 90/385/EEC 05-Sep-2007 + (Legal act)