Description: In today’s dynamic global regulatory environment, the practice of regulatory intelligence (RI) has evolved beyond passive monitoring and into a strategic, cross-functional capability that actively informs decision-making across the drug development lifecycle. As organizations expand geographically, scale their pipelines, and adopt digital transformation tools like artificial intelligence (AI), regulatory intelligence must likewise transform to remain relevant and impactful.
This presentation explores how RI can be embedded within an evolving biotech or pharmaceutical organization to provide maximum strategic value. Emphasis will be placed on the integration of RI with global regulatory development teams, its alignment with senior leadership and enterprise goals, and its collaboration with functional partners including clinical development, medical affairs, government affairs, commercial, and market access. The talk will also highlight practical use cases, including AI-based tools that enhance the collection, analysis, and dissemination of regulatory intelligence—streamlining workflows, improving predictive capabilities, and enabling more agile decision-making.
Learning Objectives:
Define the evolving role of regulatory intelligence in organizations undergoing growth, globalization, or transformation
Describe methods for embedding RI within global regulatory development to influence strategy and mitigate risks early
Demonstrate how RI can engage senior leadership, including how to frame insights in a business-relevant context
Illustrate cross-functional collaboration models where RI supports departments such as clinical development, government affairs, and commercial
Evaluate the use of AI tools in regulatory intelligence, including advantages, limitations, and integration challenges
Apply a capability maturity model for RI functions to assess current state and identify pathways to scale influence and impact
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