RGA 1080 — Pharmaceutical Regulatory Affairs

3 semester hoursUndergraduateLecture

Introduces global regulatory affairs for pharmaceuticals. Covers the roles of major regulatory agencies that ensure drug efficacy, safety, and quality. Studies the drug approval process from early development through marketing authorization in various markets. Surveys marketing authorization procedures in the United States, European Union, United Kingdom, Japan, Australia, India, and selected emerging markets, as well as international harmonization guidelines that facilitate global submissions.

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