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2022 RF Quarterly Q3

RF Quarterly,  September 2022:
Regulatory strategy

Welcome to the September issue of RF Quarterly, in which global regulatory experts write about the key elements of regulatory strategy throughout the product lifecycle, CMS regulatory strategy, the application of project management strategies to postapproval CMC submissions, and medical writing strategies for aligning regulatory documents with strategic goals.

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Table of Contents

1    Introduction
          Renee Matthews
4    Elements of global regulatory strategy — The basics
         Neal E. Storm, DRSc, MS, MBA, RAC  •  Monica Batra, MS, RAC (US, CAN)
21  An introduction to regulatory strategy
           Darin S. Oppenheimer, DRSc, FRAPS, RAC  •  Jessica L. Hale, PharmD  • 
           Suraj Ramachandran, MS, RAC  • George A. Cusatis, MS RAC
31  CMC regulatory strategy
           Stephen Antonelli, PhD  •  Michael Craig, BSc Pharm, MPSI
42  Application of project management strategy to postapproval CMC submissions
           Emily A. Rapp, RAC-US  •  Rebecca Imperial, PMP, RAC-Drugs
53  Medical writing strategies: Aligning regulatory documents with strategic goals
           Kathryn Wekselman, PhD, RN

Upcoming in RF Quarterly  
  • Artificial intelligence (December 2022)
Previous issues

To contribute, email Renee Matthews, Senior Editor, at rmatthews@raps.org

For more information, see:
Guidelines for Authors • 2022 Editorial Calendar • 2023 Editorial Calendar

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