Preconference Workshop: Locating and Analyzing Regulatory Precedent; Incorporating Research and Application Techniques in Strategic Regulatory Decision Making

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.

Hands-on exercises will be incorporated throughout the workshop to familiarize the attendees with the skills needed to locate and analyze precedent, emphasizing both basic research and the use of Generative AI systems. Please bring a powered up laptop. We will be using both free and fee-paid (deep research) versions of Generative AI tools.

And bring those tough to answer questions (please ensure that all confidential business information is not included) for the group to work on in real time.



Preconference Workshop Agenda:

7:30 – 8:30 AM: Networking Breakfast & Welcome for Workshop Registrants

8:30 AM: All Preconference Workshops Begin

8:30 – 9:00 AM: Regulatory Precedent Basics (Speaker(s): Linda Bowen)

9:00 – 9:45 AM: US Regulatory Precedent (Speaker(s): Linda Bowen)

9:45 – 10:30 AM: Research Techniques (Speaker(s): Chris Whalley)

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Registrants

11:00 – 12:30 AM: Using Generative AI to locate Precedent, including best practices for creating an AI prompt (Speaker(s): Chris Whalley, Jeff MacDonald, and Aleksandr Merenkov)

12:30 – 1:30 PM: Lunch & Networking for Preconference Workshop Registrants

1:30 - 2:15 PM: Precedent in the EU, Canada, Australia, and Japan (Speaker(s): Linda Bowen)

2:15 – 3:00 PM: Building Custom Generative AI Tools for Regulatory Research (Speaker(s): Chris Whalley, Jeff MacDonald, and Aleksandr Merenkov)

3:00 – 3:15 PM: Refreshment Break for Preconference Workshop Registrants

03:15 - 4:00 PM: Generative AI Use Cases – Bring your questions! (Speaker(s): All)

4:00 PM: All Preconference Workshops Adjourn for Day