Evolving From Compliance Enablement to Strategic Value: Driving Further Adoption of Digital Tools in Regulatory Affairs and Lessons Learned From Global RIM Implementations (Sponsored by KPMG)

Many of the common tools and technology within the Regulatory Affairs ecosystem are focused on registration/submission data tracking and document management/publishing. Investments in these tools have helped enable compliance and helped to consolidate regulatory information globally. However, these tools are still not typically perceived as enabling the day-to-day strategic activities within most Regulatory organizations. This presentation will provide practical ideas for enabling Regulatory Affairs activities through emerging technology and automation tools to help drive decision making, streamline time consuming analysis activities, and improve global coordination. Practical use cases will be covered, along with perspective on how to gain further traction within Regulatory teams on these types of tools and effectively scale them within the organization. Finally, the presentation will also cover lessons learned from global Regulatory Information Management (RIM) implementations for both pharma and medical device companies.