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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.

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Session 5 Track 2 - Submission Production Potpourri

Session Chair(s)

Daniel Orfe, MS

Daniel Orfe, MS

President and CEO

Regulatory eSubmissions, LLC, United States

This session will cover a range of submission production topics spanning blinded study IND eCTD submissions, outsourcing strategies, and dealing with major versus daily submission activities. 1) Best practices and scenarios supporting eCTD INDs during blinded study trials. Information security, contingency planning, application maintenance, PV - Regulatory transitions, and meeting safety reporting deadlines will be covered. 2) Insight and challenges associated with simultaneous management of major and routine submissions will be reviewed. Emphasizing the criticality to maximize resourcing for quality, time effectiveness, and workload distribution. 3) How internal submission capabilities should frame your core operational strategy will be outlined. Best practices for selecting the best vendor for your organization's needs based on your internal structure, technology, and support.

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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