Ressources

Ressources

Ressources Text

European Commission
EMA (European Medicines Agency)
MHRA (UK competent authority)
BfArM (German competent authority)
AGES (Austrian competent authority)
ANSM (French competent authority)
FDA (USA competent authority)
- http://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
  (21 CFR Title Search)
- http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
  (Warning Letters)
- http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
  (Guidance Documents)
ICH (International Conference on Harmonisation)
Guidelines for GCP
EudraLex
(links to all available downloads of guidance documents)
HHS
Edition of the International Compilation of Human Research Standards
International Standards Organisation (ISO)
National Institute of Standards and Technology (NIST)
Institute of Electrical and Electronics Engineers (IEE)
Federal Office for Information Security
German Society for Good Research Practice
Research Quality Association
Drug Information Association
Society of Good Clinical Data Management