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Keys to Managing a Successful Regulatory Strategy and Submission
Session Chair(s)
Lauren Neighbours, PhD, RAC
Sr. Director and Head, Regulatory Affairs, Istari Oncology, United States
This forum will discuss tools for implementing an effective regulatory submission strategy. A panel of experts will provide their insight on best practices for early, mid, and late-phase product development planning.
Learning Objective : Evaluate tools that can help manage a product development plan; Summarize best practices for preparing for and executing a regulatory submission.
Speaker(s)
Targeted Labeling Is the Key to Your Marketing Application Strategy
Diana E Bytnar Fordyce, PhD, MS, RAC
Regulations Pharmaceuticals , Consultant, Switzerland
Seven Recommendations for Building a Better NDA
Jeff Antos
Vice President, The Weinberg Group Inc., United States
Questions to Consider Before Assembling Your eCTD
Robert Rohde
Head of Submissions, Pharmakey LLC, United States
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Ways to register
Registration override should work.