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Session 6 - Track 3: Leveraging Outsourcing for Submission Production: Three Organization's Experiences with Outsource Partnering for Submission Production

Track:
Track 03

Day & Time:
October 17, 10:30AM - 12:00PM

Room Number:
Golden West

Type:
Session

Title:
Session 6 - Track 3: Leveraging Outsourcing for Submission Production: Three Organization's Experiences with Outsource Partnering for Submission Production

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

Description:
The Life Science industry is turning to specialized resources to meet the business needs of their organizations. A key area for the use of skilled partners is in the compilation of regulatory documents into electronic submissions assembled for delivery to regulatory authorities worldwide. This session will discuss opportunities for leveraging outsource partners from the perspectives of three pharmaceutical/biotechnology companies.

Presentation(s) & Speaker(s):
Submission Outsourcing: Stop Working For it, Make it Work For You
Karen Towns
Pfizer, Inc, United States

Partnering with a Vendor to Create a Strategic Productivity Center
Monica Jean Kennedy, MS,RAC
Senior Manager, GRAAS Operations & Quality Management
Amgen Inc., United States

Experiences of an Emerging Pharma Company with Submission Outsourcing
Monte Levinson
President
Aerie Canal Consulting, LLC, United States

© 2014