Strategy and Regulatory Intelligence (RI) Primer: How to Construct and Maintain it Using AI Tools

Preconference Workshop Description: Regulatory strategy, how a company meets regulatory requirements and adapts to the changing landscape, is critical for a product to move through development to approval. Regulatory Intelligence (RI) is the method you use to make sure that strategy stays current through monitoring the regulatory landscape and addressing team questions as they arise. There are many free and for fee tools available to create and maintain strategy and conduct RI. Recently, new tools and technologies like artificial intelligence (AI) have emerged to augment and streamline the creation and generation of both strategy and RI.
AI has transformed industries through unprecedented automation of tasks previously requiring human intelligence. Within regulatory spheres, AI holds immense potential to expedite traditionally manual and labor-intensive processes. This interactive pre-conference workshop explores the use of AI as an augmentation tool for both regulatory strategy and intelligence across drugs, biologics, and devices.
This workshop will cover the basics of regulatory strategy, RI, AI, machine learning (ML), large language models (LLM), and the use of free and for fee AI tools to generate output for both regulatory strategy and intelligence. The instructors will guide participants through hands-on use of free and for fee AI tools to generate:

• Information and responses to questions for product teams


• Development of strategy, regulatory pathways, including the use of past precedents


• Summaries of draft and final guidance documents


• Labeling claims


• Submission outlines, including indication overviews

The instructors and attendees will discuss common pitfalls and mistakes to avoid while using this technology. Through hands-on demonstrations, this workshop will raise participants’ comfort-level in using AI tools, enabling them to immediately apply these lessons to expedite regulatory strategy and RI activities. In addition, the presenters will share tips and tricks for both presenting strategy and intelligence to all levels of an organization.

Proposed Preconference Workshop Agenda Outline:

8:30-9:00: Introduction to regulatory strategy generation and components 

9:00-9:30: Introduction to regulatory intelligence and common deliverables

9:30-10:00: Introduction to AI and Machine Learning (ML)

10:00-10:30: Introduction to Large Language Models (LLM) and how to use them

10:30-11:00: Break

11:00-11:30: LLM demonstrations

11:30-12:00: Fee and For Free AI Tools currently available

12:00-12:30: LLM exercises for construction of either strategy or intelligence

12:30-1:30: Lunch

1:30-2:00: Sharing LLM experiences and feedback

2:00-2:30: More LLM strategy and intelligence exercises

2:30-3:00: Fee tool presentation

3:00-3:15: Break

3:15-3:45: Exercises using For Fee tools

3:45-4:00: Discussion and Wrap up