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Composite reference identifier for a Document page.
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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
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ANNEX I
TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP:
INVESTIGATOR SITE 2022 +
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 +
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
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GUIDELINE ON
THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY:
NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 +
EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) +
EU EudraLex – Volume 10 - +
EU Eudralex - volume 4
GMP Guidelines
Annex 11 Jan-2011 +
EU Eudralex - volume 4
GMP Guidelines
Chapter 4 Jan-2011 +
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 +
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 +
EU GVP: Module VIII
EMA/813938/2011 Rev. 3 (2017) +
EU GVP: Module XVI
EMA/204715/2012 Rev. 3 (2024) +
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
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Classification and analysis of the GCP inspection findings
of GCP inspections conducted at the request of the CHMP 2012 +
EU MDCG Guidelines - +
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 +
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 +
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 +
EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble +
