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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
Consultant, Switzerland
Regulations Pharmaceuticals
Seven Recommendations for Building a Better NDA
Jeff Antos
The Weinberg Group Inc., United States
Vice President
Questions to Consider Before Assembling Your eCTD
Robert Rohde
Pharmakey LLC, United States
Head of Submissions
注册方法
Registration override should work.