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Virtual Event

2022 年 06 月 13 日 10:00 上午 - 2022 年 06 月 13 日 1:00 下午

(Eastern Standard Time)

“Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You


Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

The 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 of drugs and biologics, 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.


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. 


At the conclusion of this short course, participants should be able to:
  • Recognize the importance and context of precedent in drug and biologics regulatory strategy
  • Identify and analyze precedent from EU and US health authority databases
  • Assess the impact of precedent for regulatory decision-making