Links
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General EU regulations: Volume 9
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm
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General EU regulations: Volume 10
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol10_en.htm
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EU clinical trial directive
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:EN:PDF -
E2A: Clinical Safety Data Management: Definitions and standards for expedited reporting
http://www.ich.org/LOB/media/MEDIA436.pdf -
E2B: Revision of the ICH guideline on clinical safety data management data elements for transmission of individual case safety reports
http://www.ich.org/LOB/media/MEDIA632.pdf -
EudraVigilance
http://eudravigilance.emea.europa.eu/highres.htm