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Session 5 Track 2 - Submission Production Potpourri
Learning Objective : 1) Describe challenges of balancing major and routine submissions in large organizations. 2) Discuss resource models or programs initiated such as cross functional/global work-sharing.
Speaker(s)

Challenges Encountered Supporting Both Brands and Generics – a Publishing Point of View
Kristin Wehr
Teva Pharmaceuticals, United States
Publishing Associate

eCTD IND Submission Support for Blinded Trials – Successful Options and Best Practices Considered
Meghan Alice Demollari
Accenture, United States
Regulatory Operations Manager

Determining Core Operational Strategy Using Internal Capabilities
Heather Susan McIntosh
BTG International Inc., United States
Regulatory Operations Manager
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