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Program Code:
405
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
Bhanu Bahl,
PhD,MA,PMP (SCHNON), Director, Clinical and Translational Science Center,
Harvard University, United States
Bhanu Bahl is a Senior Manager in CSOP at sanofi. She is a physician and an informatician by training; graduated with Masters & a PhD in Biomedical Informatics from Columbia University and UMDNJ , respectively; Bhanu is Program Mgr for Microsoft lifesciences innovation award winner CRUISE program.
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SPEAKER
(S):
Mitzi S Allred, PhD (SPKNON), Assistant Director, R&D Technical Information, Mgmt Clinical Sciences, Sanofi, United States
Michael J. Brennan,
PhD (SPKNON), Director, Translational Informatics,
Johnson & Johnson Pharmaceutical Research & Development, LLC, United States
Dr. Brennan has been in the pharmaceutical industry for over 20 years. He is a Director of Informatics. He was the the business owner for a cross-company regulatory information system that is being developed within J&J. Prior to this role, Michael was VP of Global Regulatory Operations at Centocor.
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Bryan Souder is an Associate Director at Merck. He has a BS from Radford University, a Six Sigma Greenbelt, and 18 years of clinical trial research experience. His current focus is being an eTMF “Global Implementation Lead”. He has conducted eTMF application & process training in 18 countries.
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Description
Document management systems have been in use by the biotechnology/pharmaceutical industry for decades. Early efforts focused on a central repository approach using first generation technology; this was costly, failure-prone and limited in scope. Sponsors have gained new perspectives through these experiences and intensified efforts to implement advanced content management platforms to increase efficiency, expand and educate new users and address global business / regulatory challenges. This session will explore methods and use cases for how sponsors are revitalizing their content management strategies and platforms to address enterprise needs and how they are gaining new ground and reaping larger benefits.