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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

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.


Kristin  Wehr

Challenges Encountered Supporting Both Brands and Generics – a Publishing Point of View

Kristin Wehr

Teva Pharmaceuticals, United States

Publishing Associate

Meghan Alice Demollari

eCTD IND Submission Support for Blinded Trials – Successful Options and Best Practices Considered

Meghan Alice Demollari

Accenture, United States

Regulatory Operations Manager

Heather Susan McIntosh

Determining Core Operational Strategy Using Internal Capabilities

Heather Susan McIntosh

BTG International Inc., United States

Regulatory Operations Manager

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