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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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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.
1 Introduction Renee Matthews HTML 4 Elements of global regulatory strategy — The basics Neal E. Storm, DRSc, MS, MBA, RAC • Monica Batra, MS, RAC (US, CAN) HTML 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 HTML 31 CMC regulatory strategy Stephen Antonelli, PhD • Michael Craig, BSc Pharm, MPSI HTML 42 Application of project management strategy to postapproval CMC submissions Emily A. Rapp, RAC-US • Rebecca Imperial, PMP, RAC-Drugs HTML 53 Medical writing strategies: Aligning regulatory documents with strategic goals Kathryn Wekselman, PhD, RN HTML
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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