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.
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.
David manages a group of regulatory affairs professionals who provide support for global categories at GlaxoSmithKline Consumer Healthcare. These global categories include Pain Management, Respiratory, Gastrointestinal, and Smoking Reduction and Cessation.
Dr. Ganley has been at FDA since 1989. For the past 12 years, he has been involved in the regulation of nonprescription drugs, specifically the development of OTC drug monographs and the switch of prescription drugs to OTC.
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.