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DIA 2021 Global Annual Meeting

Modernizing CMC Dossier Format and Review

Session Chair(s)

M. Scott Furness, PhD

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)

Nina S. Cauchon, PhD, RAC

Streamlining CMC Information in Regulatory Submissions Using Structured Content and Data Management (SCDM)

Nina S. Cauchon, PhD, RAC

  • Director Regulatory Affairs CMC
  • Amgen, United States
Larisa Wu, PhD, MS

Modernizing Drug Substance Assessment Through KASA

Larisa Wu, PhD, MS

  • Chemist, ONDP, OPQ, CDER
  • FDA, United States
Norman Robert Schmuff, PhD

FDA Update

Norman Robert Schmuff, PhD

  • Associate Director for Science, OPMA, OPQ
  • FDA, United States