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Session 9 Track 4: Managing Chaos, Time and Submissions: Organizing and Executing Global Submission Strategy
Session Chair(s)
Sandra Krogulski, MA
Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States
Companies are looking to ensure patients across the globe benefit from new and innovative medicines they are developing. To operations and submission management organizations, this means searching for new and innovative ways to manage global submissions. Teams need to maximize agility, absorb changes in volume, and ensure continuous improvement all while working to support mutliple different specifications, information requests and often submission format. As we look towards to the future of submissions and eCTD, companies must ensure that they are familiar with the requirements for new regions adopting eCTD and understand the impact to their submissions. This is about so much more than just technology; establishing your organizational maturity with a focus on people and processes will be key to your success.
Learning Objective : At the conclusion of this session, participants should be able to:
- Appraise current procedures/processes and look to refine/streamline operations
- Apply lessons learned and case studies to their own companies/departments, and understand if there is room to change or re-organize operations
- Identify and Implement best practices for supporting global teams and submissions
Speaker(s)
Harmonizing and Building a Regulatory Operations Culture and Brand during a Global Pandemic
Jillian E. Carinci, MS
Biogen, United States
Senior Director, Head of Submission Sciences
Global Submissions in a Global Company
Nichelle Ann Sage
Bristol-Myers Squibb, United States
Associate Director, Regulatory Information and Submission Management
Follow Up: Bayer’s Global Submission Support
Qian Liu, MSc
Bayer Healthcare Company Ltd., China
Regulatory Submission Manager