Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-502-L04-P; CME 2.75; IACET 2.75; RN 2.75
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This intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.
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DIA 2021 Who should attend? This short course is designed for members involved in: Regulatory affairs, regulatory intelligence and policy professionals, professionals engaged in regulatory research and precedent analysis to support regulatory decision-making.
Learning Objectives Describe the importance and context of precedent in regulatory strategy; Discuss locating and analyzing precedent from EU and US drug and biologic sources;Identify the impact of precedent for regulatory decision-making.
