eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
350
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
253B
CHAIR
:
Daniel F. Orfe, MS (SCHNON), President and CEO, Regulatory eSubmissions, LLC, United States
Assoc Dir, Reg Ops, Teva, President, Regulatory eSubmissions, LLC. Previously, VP Global Sub Services, Datafarm Inc. and Assoc Dir of Merck's Regulatory Electronic Submissions group for 10 years. He's was Merck's PhRMA's ERS rep for 10 yrs. MS CIS: NJ Inst. of Tech. & BS Chem.: Ramapo College NJ.
SPEAKER
(S):
Daniel F. Orfe, MS (SPKNON), President and CEO, Regulatory eSubmissions, LLC, United States
Karen Towns, (SPKNON), Senior Director and Global Head, Publishing and Product License Support, Pfizer Inc, United States
With 14 years in Pharma Regulatory Operations, Karen has led submission delivery for many regions. She has installed publishing technologies, submission and global document management models. Karen is now responsible for Pfizer’s 24/7 global Publishing and Product License support.
Cortney A Gilbert, MBA,MS (SPKNON), Associate Director, Global Regulatory Operations, Merck & Co., Inc., United States
Cortney Gilbert is an Associate Director within the Global Regulatory Operations department at Merck & Co., Inc. He has more than 15 years industry experience, and holds an M.B.A., with a focus in Information Systems, as well as an M.S., with a focus in Regulatory Affairs.
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.