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Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor's Organization: Retooling R&D for ERS
Program Code:
373
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Peter M. Lassoff,
PharmD (SCHNON), Vice President and Head of Global Regulatory Affairs,
Quintiles, Inc., United Kingdom
Dr. Peter Lassoff, Pharm.D., is Vice President and Head, Global Regulatory Affairs for Quintiles. Peter is responsible for a large group of regulatory professionals for the only fully integrated bio and pharmaceutical services provider, offering regulatory execution and strategic services.
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SPEAKER
(S):
Peter M. Lassoff, PharmD (SPKNON), Vice President and Head of Global Regulatory Affairs, Quintiles, Inc., United Kingdom
Murali Chandrashekar, MBA (SPKNON), Sanofi, United States
Jeffrey S. Morrison,
MS (SPKNON), Director, Global Regulatory Operations,
GlaxoSmithKline, United States
Over ten years experience in Global Regulatory Operations, with emphasis on submission publishing, submission management, lifecycle maintenance and global dossier production. Experience with various eCTD publishing tools and systems, submission requirements and submission planning software.
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Description
This session will assist pharmaceutical companies in reorganizing their R&D departments to fit the requirements of electronic regulatory submission development. This will speed up the writing and submission of eCTDs and other electronic submissions leading to faster time to market.