Back to Agenda
Session 9 Track 4: Managing Chaos, Time and Submissions: Organizing and Executing Global Submission Strategy
Session Chair(s)
Sandra Krogulski, MA
Senior Director, Regulatory Digital Strategy and External Engagement, Bristol Myers Squibb, 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
Senior Director, Head of Submission Sciences, Biogen, United States
Global Submissions in a Global Company
Nichelle Ann Sage
Associate Director, Regulatory Information and Submission Management, Bristol-Myers Squibb, United States
Follow Up: Bayer’s Global Submission Support
Qian Liu, MSc
Regulatory Submission Manager, Bayer Healthcare Company Ltd., China
Have an account?