This course will review regulatory precedent (and the pathway to locate, assess, and integrate) as a global regulatory strategic driver. Precedent case studies will be used to identify challenges when limited information is publicly available and how to interpret precedent. Attendees will engage through analysis of a hypothetical development program and explore the types of questions that would be critical to successfully integrate precedent for regulatory success.

An additional registration fee is required for all preconference short courses.

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