DIA 48th Annual Meeting
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Effective Switching from Rx to OTC Status: Maximizing Revenue and Profit From Off-Patent Products
Track : Track 08: Regulatory Affairs and Submissions
Program Code: 111
Date: Monday, June 25, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Peter Lassoff, Quintiles, United Kingdom
PRESENTER (S):
 Peter Lassoff, Quintiles, United Kingdom
 David Schifkovitz, GlaxoSmithKline Consumer Healthcare, United States
 Charles Ganley, FDA, United States
Description
This session will provide an insight into the complex regulatory issues associated with switching of medicines to OTC status and strategic insights into how to use OTC switching to extend protection against competitor companies as patent expiry approaches.

Learning Objectives:
Discuss the rationale behind government support for OTC switches and commercial case for switching
Discuss successes and failures with case studies of recent switches.