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Session 7 Track 4: Strategies to Achieve Global Regulatory Operations Excellence
Session Chair(s)
Kevin Tompkins, MBA
Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States
The present global regulatory environment requires companies to be agile, cost efficient, and effective in their daily operations. Regulatory operations often deal with tight deadlines, last minute changes, and are pushed to accelerate timelines. In order to achieve successful submissions, operations teams need to leverage teamwork, streamlined processes, and effective planning. Focused strategies that facilitate communication and global operations are the foundation for successful submissions. This session will review suggestions and strategies for building a successful team that can tackle the daily challenges teams face while working towards an efficient future state.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify strategies for increasing the efficiency and quality of your regulatory operations team
- Apply best practices and continuous quality improvement to your global submissions processes
- Manage initiatives for improved collaboration and resource management
Speaker(s)
Building a Global Regulatory Operations Team
Paul Miller, MBA
Alnylam Pharmaceuticals, United States
Senior Director, Regulatory Technology, Operations and Filing Excellence
Working Smarter, Not Harder: The Future of Globalization
Olga Alfieri, MBA, MSc, RAC
Eisai Pharmaceuticals, United States
Senior Director, Global Submission Management & Operations
Resourcing a Reg Ops Team: Which Model Fits Best for You
James Hendry
GE Healthcare, Pharmaceutical Diagnostics, United Kingdom
Head of Global Regulatory Operations
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