BIOL 583 Regulation of Domestic and Global Biotechnology Products
Learn the regulatory process for biologicals and biotechnology medicinal products ranging from Investigational New Drug Applications to post-marketing approval changes and expanded new clinical applications. Both domestic (FDA) and international (including developing country) regulatory processes will be discussed. Topics will include FDA regulations, international regulatory harmonization efforts, WHO recommendations, Good Practices, product and control information, preclinical studies and clinical trials to support regulatory filings, human subject protection regulations, and ethical review processes.