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List of results
- Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 + (DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988)
- Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 + (DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022)
- Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 + (DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021)
- Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 + (DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024)
- Document:EU 2011/C 172/01 - CT-3 11-Jun-2011 + (EU 2011/C 172/01 - CT-3 11-Jun-2011)
- Document:EU CHMP Guidelines - + (EU CHMP Guidelines -)
- Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 + (EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022)
- Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 + (EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12)
- Document:EU EMA Guidelines - + (EU EMA Guidelines -)
- Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 + (EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022)
- Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 + (EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017)
- Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 + (EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021)
- Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 + (EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022)
- Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 + (EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023)
- Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 + (EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023)
- Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 + (EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022)
- 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 + (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)
- Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 + (EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005)
- Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) + (EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023))
- Document:EU EudraLex – Volume 10 - + (EU EudraLex – Volume 10 -)
- Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 + (EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011)
- Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 + (EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011)
- Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 + (EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838)
- Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 + (EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022)
- Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) + (EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017))
- Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) + (EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024))
- 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 + (EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012)
- Document:EU MDCG Guidelines - + (EU MDCG Guidelines -)
- Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 + (EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017)
- Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 + (EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22)
- Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 + (EU Regulation (EU) 2016/679 (GDPR) 04-May-2016)
- Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble + (EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble)
- Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 + (EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023)
- Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 + (EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023)
- Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble + (EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble)
- Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 + (EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022)
- Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble + (EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble)
- Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 + (EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014)
- Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 + (EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12)
- Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 + (EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020)
- Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 + (EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023)
- Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 + (EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022)
- Document:EUR European Bioethics Convention 1997 + (EUR European Bioethics Convention 1997)
- Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 + (FRA AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiques 16-May-2025)
- Document:FRA AEC DOC010 V.04 01-Jun-2018 + (FRA AEC_DOC010 V.04 01-Jun-2018)