Designing and Maintaining a Robust Regulatory Intelligence Program

Proposal Description: The pace of innovation and change in medical device development is increasing as are changes in regulatory frameworks and standards, internationally. Maintaining awareness of these regulatory changes and providing strategic input into product development teams and the quality system are critical deliverables of modern regulatory intelligence (RI) programs. Yet little information is available on how to set up the processes & tools for a new RI program. Multiple tools exist to monitor the regulations and standards, and the trade associations share meaningful information, but it still requires regulatory professionals to manually consolidate the data and filter out the noise to transform raw information into actionable insights. So how do you balance this with a fear of missing out on critical information while alleviating the weight from day-to-day activities? How do you get support from your leadership team?

This interactive and dynamic session will discuss strategic approaches to setting up RI Programs.