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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.
Who should attend?
This short course is designed for professionals with basic knowledge in Regulatory (strategy, CMC, regulatory intelligence), Clinical, Project management, competitive intelligence, and business development.
At the conclusion of this course, participants should be able to:
Learn how to locate global regulatory precedent, assess its value and integrate to drive regulatory strategy decision making and what to do when no precedent exists.
Leverage precedent for risk assessment and mitigation planning as well as opportunities for success in approval and lifecycle management