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Friday, June 18 • 12:00pm - 1:00pm
#526 OD: Modernizing CMC Dossier Format and Review

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

M. Scott Furness, PhD

Speaker

Streamlining CMC Information in Regulatory Submissions Using Structured Content and Data Management (SCDM)
Nina S. Cauchon, PhD, RAC

Modernizing Drug Substance Assessment Through KASA
Larisa Wu, PhD, MS

FDA Update
Norman Robert Schmuff, PhD


Speakers
MS

M. Scott Furness

Deputy Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Scott Furness, Ph.D., Deputy Director, ONDP, OPQ, joined CDER’s OPS/OGD in 2000, serving as a Chemistry reviewer and team leader. In 2007, he was named Director of the Division of Nonprescription Regulation Development in the Office of New Drugs’ (OND). During his time in OND... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Norman Schmuff

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States
Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He is currently the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission... Read More →
avatar for Larisa Wu

Larisa Wu

Chemist, ONDP, OPQ, CDER, FDA, United States
Larisa Wu, Ph.D., is the Acting Associate Director for Science and Communication in ONDP/OPQ/CDER. Since she joined FDA in 2011, Larisa contributed significantly to various initiatives that became pivotal to the launch of OPQ. In her most recent roles, Larisa worked extensively on... Read More →

Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session |   20: Early Access Content, Session