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Session 6, Track 4: Achieving Regulatory Operational Excellence: People, Process, Data, Tech
Session Chair(s)
Noelia Plaza
Director of Process Excellence & Analytics, Daiichi Sankyo, United States
The session will blend key insights and learning from the fall Gens & Associates Regulatory Operational Excellence and World Class RIM study with experiences from two different sized sponsors. The session will minimally focus on 6 key areas that contribute to regulatory operational excellence: 1) process optimization / maturity, 2) KPI/Metric program effectiveness, 3) advanced technology investment priority and ROI, 4) Data Governance practices leading to high data quality levels, 5) authoring transformation (e.g. GenAI usage / ROI and 6) Regulatory Digitization progress.
Achieving Regulatory Operational Excellence: People, Process, Data, Tech
Steve Gens, Gens & Associates Inc.
DATA
Joerg Stueben, Boehringer Ingelheim International GmbH
RIM Technology Investment Priority
Sasikanth Godavarty, Otsuka
Learning Objective :
At the conclusion of this session, participants should be able to:
- Recognize what constitutes a high performing Regulatory organization
- Explain which advanced technology use cases are getting the best ROI
- Implement practical approaches for improving a regulatory KPI/Metrics Program
Speaker(s)
Achieving Regulatory Operational Excellence: People, Process, Data, Tech
Steve Gens, MS
Managing Partner, Gens & Associates, United States
DATA
Joerg Stueben, DRSc
Head of Regulatory Information Management, Boehringer Ingelheim, Germany
RIM Technology Investment Priority
Sasikanth Godavarty
Senior Director, Head of Regulatory Technology, Otsuka, United States
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