Fireside Chat: Rethinking Regulatory Information Management

RIM must evolve from a passive data repository to an "active control tower" in regulatory management.

RIM's role shifting to enable governance and fast, compliant assessments in complex environments. It has to stop being “just a storage data room.”

Effective data governance across departments is the biggest challenge and the key to successful RIM deployment.

Poor data spread and lack of harmonization require enterprise-wide culture change for better regulatory data. Much of that data sits outside the regulatory department, which gives regulatory a chance to act as a business partner to the rest of the company.

AI's critical regulatory role is automating data governance by flagging inconsistencies across disparate data sources.

AI helps identify data gaps and enables faster, strategic decision-making in regulatory operations.

Managing multi-product portfolios demands flexible RIM configuration respecting diverse product classifications and ownership.

Rigid systems struggle with diverse pharma-device-consumer product mixes across regions. The need is a single data source across regions, with the same governance rules and classification for every product category.

Transitioning from system of record to system of intelligence requires strict data governance rules and active change management.

A disciplined approach ensures data quality and adoption amid regulatory and portfolio complexity.

Regulatory teams need integrated interfaces combining system of record context with user-friendly AI assistant agents.

This integration enables streamlined regulatory work and quicker impact assessments on portfolios.