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Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access
Session Chair(s)
Libbie Mansell
White Oak Biopharma Solutions, United States
This session will cover practical aspects of managing drug development projects that incorporate both registration-directed, preapproval activities as well as reimbursement-directed, market access activities.
Learning Objective : Discuss requirements for submissions to health care technology assessment organizations that affect the development team; Identify strategies that optimize the dual needs for timely regulatory approval and appropriate pricing/reimbursement.
Speaker(s)
Generating Evidence for a NICE Technology Appraisal
Leeza Osipenko, PhD, MSc
National Institute for Health and Care Excellence (NICE), United Kingdom
Head of Scientific Advice
When Lab Scientists Meet Economic Payors: A Market Access Professional's Dilemma When You Come to Us Too Late
Chia Wen Lee
Biogen Idec, United States
Head, Emerging Markets Access
Facilitating Global Program Convergence for Optimized Registration and Market Access
Libbie Mansell
White Oak Biopharma Solutions, United States
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