This course outlines the medical and regulatory aspects of clinical research procedures and SOP development. The support functions of clinical research and regulatory affairs department (including adverse events reporting, literature reviews, post-marketing surveillance, and summary of product characteristics, label changes, advertising, patient information and safety reporting) are examined and evaluated.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.
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