eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation

Track:
Regulatory Affairs and Submissions

Day & Time:
June 26, 1:45PM - 3:15PM

Session Number:
350

Room Number:
253B

Level:
Intermediate

Type:
Session

Title:
eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation

Chair(s):
Daniel F. Orfe, MS
Assoc. Director, Global Regulatory Operations-Technology, Standards, Vendor Mgmt
Teva Pharmaceuticals USA, Inc, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Several Regulatory Operations Groups Integrated Into One: Changes to the Who, What, Where, When, Why and How of Submission Outsourcing
Daniel F. Orfe, MS
Assoc. Director, Global Regulatory Operations-Technology, Standards, Vendor Mgmt
Teva Pharmaceuticals USA, Inc, United States

Submission Outsourcing: Stop Working For it, Make it Work For You
Karen Towns
Senior Director and Global Head, Publishing and Product License Support
Pfizer Inc, United States

In/Out Sourcing: Risks and Benefits of a Hybrid Sourcing Model
Cortney A Gilbert, MBA,MS
Associate Director, Global Regulatory Operations
Merck & Co., Inc., United States