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Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
Session Chair(s)
Janel Demeter
Manager, Regulatory Operations
Accenture LLP, United States
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.
Learning Objective : Describe steps to properly and efficiently engage in the life cycle management; Discuss the most effective processes to ensure a successful collaboration; Identify how important timely and accurate communication is tied to milestone completion; Recognize what should you expect from your outsourcing partner.
Speaker(s)
Is Outsourcing Right for You? Outsourcing Trends Focusing on Small to Midsize Pharmaceutical Companies
Janel Demeter
Accenture LLP, United States
Manager, Regulatory Operations
Outsourcing Full Electronic Submission Services for Initial Applications and Life Cycle Maintenance
Sunitha Reddy Nalla, MS
Verinume, United States
Outsourcing: Transitioning Document Support Activities to an Offshoring Model
Aaron Miller
Janssen Research & Development, LLC, United States
Alliance Manager, Labeling & Submissions Management
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