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Session Chair(s)
Daniel Orfe, MS
President and CEO
Regulatory eSubmissions, LLC, United States
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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