Regulatory affairs is naturally complex, and leaders often have to work under uncertainty. Unexpected events can derail the best plans, but a lot of challenges are driven simply by a lack of visibility into regulatory timelines, resources, and needs. Effective leaders can shift the organizational posture from reactive to proactive with better planning and a comprehensive regulatory data strategy.
This session will look at regulatory processes across the product lifecycle, the information needed to properly forecast required time and resources, and provide a framework that regulatory leaders can use to build more resilient plans. Whether it’s effectively supporting the new information requirements for MDR/IVDR, prioritizing upcoming registration renewals, or ensuring the team won’t be handicapped by employee turnover, better planning can help teams operate more quickly, efficiently, and confidently.
Learning Objectives:
Participants will learn how to increase organizational visibility into upcoming regulatory needs
Participants will understand how to measure regulatory process performance across the product lifecycle
Participants will be able to identify stakeholders for collaboration and present regulatory proposals to leadership