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Modernizing CMC Dossier Format and Review
Session Chair(s)
M. Scott Furness, PHD
Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States
As several accelerated review pathways (e.g., Breakthrough Therapies) are increasingly being utilized and pressure continues to mount to bring new and generic drug products to market quickly, innovative solutions for assembling, distributing, and reviewing quality regulatory data are being considered. Examples of such innovative solutions include the Structured Content and Data Management (SCDM), Knowledge-Aided Assessment and Structured Application (KASA), and the Pharmaceutical Quality and Chemistry, Manufacturing and Controls (PQ-CMC) initiatives.
Learning Objective : Describe some of the latest developments in several initiatives to streamline compilation of quality data in regulatory submissions, including the Structured Content and Data Management (SCDM), Knowledge-Aided Assessment and Structured Application (KASA), and the Pharmaceutical Quality and Chemistry, Manufacturing and Controls (PQ-CMC) initiatives.
Speaker(s)
Streamlining CMC Information in Regulatory Submissions Using Structured Content and Data Management (SCDM)
Nina S. Cauchon, PHD
Amgen, United States
Director Regulatory Affairs CMC
Modernizing Drug Substance Assessment Through KASA
Larisa Wu, PHD, MS
FDA, United States
Chemist, ONDP, OPQ, CDER
FDA Update
Norman Schmuff, PHD
FDA, United States
Associate Director, OPMA, OPQ, CDER