DIA 2013 49th Annual Meeting
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Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 311
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 253B
CHAIR :
 Janel Demeter, (SCHNON), Manager, Regulatory Operations, Accenture LLP, United States
SPEAKER (S):
 Janel Demeter, (SPKNON), Manager, Regulatory Operations, Accenture LLP, United States
 Sunitha Reddy Nalla, MS (SPKNON), Associate Director, Regulatory Operations, Aveo Pharmaceuticals, Inc., United States
 Aaron Miller, (SPKNON), Alliance Manager, Labeling & Submissions Management, Janssen Research & Development, LLC, United States
Description
This session will focus on the value proposition of outsourcing the life cycle management of your eSubmission documents. It will harness expertise and best practices based on hands-on knowledge, past problems solved, and developing a strategic approach to the submission process to prevent issues before they happen. This session will include a case study focused on applying the large pharma model to small pharma companies and include details of a specific client engagement and lessons learned. It will also illustrate best practices, and perceived barriers and solutions based on experience. Discussions will also focus on what you should expect out of your strategic outsourcing partnership.