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Locating and Analyzing Regulatory Precedent for Drugs and Biologics
Wednesday, June 5, 2024
9:00 AM – 4:00 PM EDT
Location: Concourse C/D
This workshop will provide an overview and practical insight into locating, analyzing, and applying precedent to make 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.
Agenda Outline:
8:00 - 9:00 am: Registration and Continental Breakfast 9:00 - 9:30 am: Precedent Basics 9:30 - 10:30 am: US Regulatory Precedent 10:30 - 11:00 am: Refreshment Break 11:00 am - 12:00 pm: Search techniques including hands-on exercises 12:00 - 1:00 pm: Lunch 1:00 - 2:00 pm: Precedent in the EU, Canada, Australia and Japan 2:00 - 2:30 pm: Using Generative AI to locate precedent with case studies 2:30 - 3:00 pm: Refreshment Break 3:00 - 4:00 pm: Hands-on Exercises – Ad hoc requests to inform strategy 4:00 pm: Adjournment
Learning Objectives:
Understanding the importance and context of precedent in regulatory strategy
Locating and analyzing precedent from EU and US drug and biologic sources
Assessing the impact of precedent for regulatory decision-making
