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New Challenges from Outsourcing of Regulatory Operations
Program Code:
135
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
During 33 years with GSK, 14 as VP, Reg Ops, Steve implemented global business process change and global organisational change for GSK, including outsourcing parts of Regulatory. After leaving GSK at the end of 2010, Steve formed Originex and now offers his expertise to the industry at large.
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PRESENTER
(S):
During 33 years with GSK, 14 as VP, Reg Ops, Steve implemented global business process change and global organisational change for GSK, including outsourcing parts of Regulatory. After leaving GSK at the end of 2010, Steve formed Originex and now offers his expertise to the industry at large.
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Allen Jones, GlaxoSmithKline, United States
John Joseph,
Bristol-Myers Squibb Company, United States
John holds a BA degree in Biology from Thomas Edison College in NJ. John began his Pharma career at J&J then McNeil Lab & at BMS. In his 26 years in Regulatory Affairs, John has managed the preparation and filing of over 65 major dossiers both paper and fully electronically.
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Description
With the focus on cost reduction, the industry is progressing outsourcing of regulatory operations business processes, bringing new challenges and issues. This session will focus on how these are being overcome and the business benefits that result.
Learning Objectives:
Assess the opportunities from outsourcing of regulatory operations
Describe the issues, challenges, and solutions
Identify the benefits of outsourcing regulatory operations and its potential.