Lehigh University
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Gary Slatko

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Director, Office of Medication Error Prevention and Risk Management FDA

Gary Slatko, MD, MBA, as Chief Medical Officer, leads all aspects of risk management consulting services for ParagonRx, including strategy, design, documentation, negotiation, implementation and assessment. A pioneer in pharmaceutical risk management, he co-authored two books on the subject, established an evidence-based framework REMS program design and has led the development of over 20 RiskMAPs and REMS programs. Applying his 23 years of industry experience to failure analysis and ethnographic clinician observation yields comprehensive programs that are robust, practical, measurable and support appropriate medication use, such that interests of regulators, practitioners, patients and shareholders are all served.

Prior to co-founding ParagonRx in 2001, Gary held executive pharmaceutical positions at GlaxoSmithKline, AstraZeneca, DuPont Merck and Bristol-Meyers Squibb. He obtained his M.D. degree from the University of Miami, his M.B.A. degree from West Chester University and his B.A. degree from Emory University, and is Board Certified in Internal Medicine.