Property:DocName
From GxPlex
Full name of the regulatory document.
G
Data Protection Act 2018 +
W
Declaration of Helsinki +
D
Deutsches Ärzteblatt +
G
Directive 2001/20/EC +
E
Directive 2001/83/EC -
Community code relating to medicinal products for human use +
G
Directive 90/385/EEC +
Directive 93/42/EEC +
Directive 98/79/EC +
E
EMA Guidelines +
EMA/298712/2022 -
Complex clinical trials – Questions and answers +
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 +
EMA/431265/2016
Annex I – to guidance for the conduct of good clinical practice inspections – investigator site +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 +
EMA/698382/2021
-
Guideline for the notification of serious breaches of
Regulation (EU) No 536/2014 or the clinical trial protocol +
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 +
EMA/786433/2022
Annex V – to guidance for the conduct of good clinical practice inspections – Phase I
units +
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 +
EMA/INS/GCP/112288/2023
-
Guideline on computerised systems and electronic data in
clinical trials +
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 +
EMA/INS/GCP/126568/2023
-
Annual Report of the Good Clinical Practice (GCP)
Inspectors' Working Group (IWG) 2022 +
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 +
EMA/INS/GCP/143492/2022
-
ANNEX I
TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP:
INVESTIGATOR SITE +
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 +
EMA/INS/GCP/856758/ 2018
Guideline on the content, management and archiving of
the clinical trial master file (paper and/or electronic) +
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 +
EMEA/CHMP/313666/2005
-
GUIDELINE ON
THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY:
NEED FOR POST-AUTHORISATION DATA +
ENCePP - Guide on Methodological Standards in Pharmacoepidemiology +
D
Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 +
