Which guidelines are supposed to be learned for Regulatory affairs ?

05 May 2016 1 3K Report

which guidelines are supposed to be learned for Regulatory affairs ?

If you look at the European Medicines Agency and the FDA websites you can find guidelines relevant for regulatory people. You may wish to start from the links below.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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