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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Characterizing Drug Shortages and Their Causes: Anticipating Future Trends

Session Chair(s)

Kenneth  Getz, MBA

Kenneth Getz, MBA

Tufts Center for the Study of Drug Development

Center For the Study of Drug Development, United States

The incidence and scale of drug shortages have both increased markedly during the past several years. As a result, regulatory agencies, drug manufacturers, and policy makers have been focusing more attention on understanding drug shortages and mitigating associated risk. This session includes information on a 2012 study capturing robust descriptive and detailed data on the incidence of, and longitudinal trends in, drug shortages and where and why they occur. This session will also discuss the anticipated increase in the incidence of drug shortages under the rising proportion of biosimilars in the market and the impact of other forecasted drug development and commercialization trends.

Learning Objective : Describe the incidence and characteristics of drug shortages; Articulate why drug shortages occur; Anticipate factors that may increase the incidence of drug shortages in the future.

Speaker(s)

Richard  Dolinar, MD

Pharmacovigilance in the Age of Biosimilars: Effectively Tracking Biologic Drug Outcomes Today and Tomorrow

Richard Dolinar, MD

Bilao, LLC, United States

Chairman

David  Gaugh, RPh

Drug Shortages: An Industry Perspective

David Gaugh, RPh

Generic Pharmaceutical Association (GPhA), United States

Senior Vice President for Sciences and Regulatory Affairs

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