Science Researcher Update: Spotlight on Meetings, Conferences, and Events

This is a basic- to intermediate-level overview course, intended for individuals who have at least some experience in clinical safety of biopharmaceutical products. The focus will be on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products as used in clinical trials, in post-marketing studies, and under conditions of actual use in real-world healthcare settings.

Legal basis for safety reporting including a historical perspectiveBasic definitions and toolsEvaluation of seriousness, expectedness, and causalitySafety reporting requirements in the pre-marketing phaseData collection, processing, and requirements in the post-marketing phaseCase studies and practical exercisesActive safety surveillance in the post-marketing phaseAudits and inspectionsIntroduction to signal detection and risk assessmentBasics of risk management in the US and EUPrinciples of pharmacoepidemiology

(Courtesy of http://www.diahome.org/en/)