Spring Intro 2023

16/02/2023

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Useful Resources

Clinical Trials Directive 2001/20/EC https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 1/dir_2001_20/dir_2001_20_en.pdf ‘Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial’ - March 2010 http://ec.europa.eu/health/files/eudralex/vol10/2010_c82_01/2010_c82_01_en.pdf Clinical Trial Facilitation Group (CTFG) http://www.hma.eu/ctfg.html EUDRALEX http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm EUDRACT https://eudract.ema.europa.eu/index.html EUDRAPHARM http://eudrapharm.eu/eudrapharm/selectLanguage.do?from=true&to=false CTR 536/2014 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 1/reg_2014_536/reg_2014_536_en.pdf Your company regulatory intelligence database (if you have one!)

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