戻る Agenda
Session 9 Track 2: Lessons Learned in Advancing Data Based RIM and the Practical Application of Governance Frameworks
Session Chair(s)
Kristen Sauter, MBA
Senior Director, Head, Global RIM, Analytics & Digital Innovation
Takeda Pharmaceuticals, United States
Katherine Novak, MS
Principal Product Manager
Accumulus Synergy, United States
As innovative technologies have become more accessible, most R&D and Regulatory Affairs departments are increasingly focused on data platforms, digital transformation and data science as strategic imperatives. However approaching these strategic imperatives can be complex and organizations will need a multi-faceted approach. This session will share perspectives on ensuring the readiness of regulatory organizations, professional skills development, change management and organizational transition. In addition, the session will dive deeper with a real-world business case study on moving through integration of two large sized organizations to a harmonized platform with E2E business processes and harmonized data. And, lastly, this session will review the role of data management and governance to enable greater data sharing.
Learning Objective : At the conclusion of this session, participants should be able to:
- Evaluate impacts of Digital Transformation on the Regulatory workforce
- Reference the approach of program management of a large, global implementation
- Learn about establishing a trusted and true data management and governance framework
Speaker(s)
Case Study: Takeda’s RIM Journey through Integration and move to a New Platform
Margo Tyler-Mcwilliams
Takeda Pharmaceutical Company Limited, United States
Associate Director, Regulatory Informatics and Analytics
Trusted and True: The Role of Data Management and Governance to Enable Greater Data Sharing
Maria Sagoua, MHA
Accumulus Synergy, United States
Director of Regulatory Innovation
Enabling a Digital-Ready Workforce in Regulatory
Brian Williams
KPMG, United States
Advisory Managing Director, Life Sciences