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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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