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eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation
Session Chair(s)
Daniel Orfe, MS
President and CEO
Regulatory eSubmissions, LLC, United States
This session will explore the approach taken by three life science companies for leveraging eSubmission outsourcing. The specific challenges and opportunities for outsourcing resulting from ongoing mergers and acquisitions will be examined.
Learning Objective : Discuss the approach three life science companies take when utilizing outsource partners for eSubmission production; Describe how ongoing mergers and acquisitions impact eSubmission outsourcing strategy; Identify what to consider when choosing an eCTD outsource partner.
Speaker(s)
Several Regulatory Operations Groups Integrated Into One: Changes to the Who, What, Where, When, Why and How of Submission Outsourcing
Daniel Orfe, MS
Regulatory eSubmissions, LLC, United States
President and CEO
Submission Outsourcing: Stop Working For it, Make it Work For You
Karen Towns
Pfizer, United States
VP, Global Head of Publishing & Product License Support
In/Out Sourcing: Risks and Benefits of a Hybrid Sourcing Model
Cortney A Gilbert, MBA, MS
Merck & Co., Inc., United States
Associate Director, Global Regulatory Operations
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