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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

FDA Innovation in Pharmaceutical Quality Assessment and Inspection

    Session Chair(s)
      Christine M. V. Moore, PhD

      Christine M. V. Moore, PhD

      • Global Head and Executive Director, GRACS CMC - Policy
      • Merck Research Laboratories, United States
    FDA’s Office of Regulatory (ORA) and Office of Pharmaceutical Quality (OPQ) within CDER work closely together to provide “one quality for voice” for products including new drugs, biotechnology products, generic drugs, and over-the-counter drugs. Many changes and innovation have occurred since the 2015 stand up of OPQ and the 2017 program alignment within ORA. This session will discuss some of the innovative approaches being used within OPQ and ORA to provide more focused and patient relevant quality assessments, promote review efficiency and innovation for generic drugs and to integrate quality assessment and inspection.`
    Learning Objective : Identify the ongoing FDA initiatives to modernize and integrate the quality assessment and inspection processes for drugs.
      Susan M. Rosencrance, PhD

      Modernization of Quality Assessment of Generic Drugs

      Susan M. Rosencrance, PhD

      • Director, Office of Lifecycle Drug Products, OPQ, CDER
      • FDA, United States
      Ashley  Boam, MS

      Patient-Focused Quality Within OPQ: Clinically Relevant Specifications and Quality Overall Summary

      Ashley Boam, MS

      • Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
      • FDA, United States