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List of results

• Document:EU 2011/C 172/01 - CT-3 11-Jun-2011  +
• Document:EU CHMP Guidelines -  +
• Document: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  +
• Document:EU EMA Guidelines -  +
• Document: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  +
• Document: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  +
• Document: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  +
• Document: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  +
• Document: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)  +
• Document:EU EudraLex – Volume 10 -  +
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  +
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  +
• Document: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)  +
• Document: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  +
• Document:EU MDCG Guidelines -  +
• Document: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  +
• Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016  +
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  +
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023  +
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble  +
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023  +
• Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022  +
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  +
• Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014  +
• Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12  +
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  +