FDA
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US Food and Drug Administration (FDA) |
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http://www.fda.gov |
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FDA Code of Federal Regulations; Title 21 |
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm |
EC
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|
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European Commission (EC) |
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http://ec.europa.eu/index_en.htm |
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EudraLex Rules Governing Medicinal Products in the EC |
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http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm |
MHLW
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|
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Japanese Ministry of Health Labor and Welfare |
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http://www.mhlw.go.jp/english/index.html |
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Pharmaceutical Administration and Regulations in Japan |
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http://www.nihs.go.jp/mhlw/jouhou/yakuji/yakuji-e0703.pdf |
ICH
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|
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International Conference on Harmonisation (ICH) |
| |
http://www.ich.org/cache/compo/363-272-1.html |
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ICH Quality Guidelines |
| |
http://www.ich.org/cache/compo/276-254-1.html |
HIPAA
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|
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US Department of Health & Human Services (HHS) |
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http://www.hhs.gov |
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Health Insurance Portability and Accountability (HIPAA) |
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http://www.hhs.gov/ocr/hipaa/ |
SOX
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|
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US Securities and Exchange Commission (SEC) |
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http://www.sec.gov |
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SEC Sarbanes-Oxley Act (SOX) |
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http://www.sec.gov/about/laws/soa2002.pdf |
PIC/S
|
|
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Pharmaceutical Inspection Cooperation Scheme (PIC/S) |
| |
http://www.picscheme.org/index.php |
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PIC/S Guides |
| |
http://www.picscheme.org/index.php?p=guides |
Resources
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|
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Praxis Learning Networks |
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Software Validation Training and Consulting Services |
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http://www.praxisln.com |
