Harnessing Regulatory Intelligence to Drive Change: Lessons Learned from Industry Forum and Individual Company Approach

Developing a robust Regulatory Intelligence strategy and investing in Regulatory Intelligence technology, and resources enables an organization to anticipate changes, develop opportunistic innovative strategy, mitigate risk, increase operational efficiency, and reduce non-compliance. Regulatory intelligence is an essential function that creates value by effectively managing, integrating, and leveraging internal and external data throughout the full product lifecycle enabling faster more efficient registration and keeping legacy products on the market. The exponential growth and access to information are driving advances in technology that can create a single source of truth (e.g. via a centralized repository). Regulatory intelligence is not a one size fits all function. It is important to identify what is most relevant to an organization, to develop a program adapted to fit that organization’s unique requirements and needs. This session will share lessons learned from two frameworks, an industry forum and an individual company practical case study. It will demonstrate that a thoughtfully designed regulatory intelligence framework can add value and a competitive advantage regardless of company size and will share concrete ways to get started (e.g. within regulatory strategy) and opportunities to expand stepwise.