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Drug Development Phase 3 and Regulatory Review

Review phase 3 clinical study activities and the regulatory requirements and components of an application for marketing approval in the US and EU.

Authors

Stephen V.  O'Quinn, PharmD

Stephen V. O'Quinn, PharmD

President, Perissos, Inc., United States

Stephen O’Quinn, PharmD, is the founder and President of Perissos, Inc which specializes in helping clients drive business results through insight-driven marketing and medical strategies. Stephen spent over 20 years with GlaxoSmithKline in senior leadership roles in both marketing and medical functions-- from medicines development through commercial product launch and lifecycle management. Stephen's marketing leadership roles included serving as Senior Director for 12 brands across five different therapeutic areas. Stephen holds a Doctor of Pharmacy degree, with highest honors, from the University of North Carolina at Chapel Hill.

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