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  6. Office of Program and Regulatory Operations | Pharmaceutical Quality
  1. CDER Offices and Divisions

Office of Program and Regulatory Operations | Pharmaceutical Quality


Who We Are

The Office of Program and Regulatory Operations (OPRO), part of CDER’s super Office of Pharmaceutical Quality, leads and manages assessment related project management.

What We Do

  • Oversees the operations and regulatory processes associated with quality assessments (including inspection) in collaboration with other offices in The Office of Pharmaceutical Quality (OPQ), The Center for Drug Evaluation and Research (CDER), and The Food and Drug Administration (FDA).
  • Provides leadership in program and project management to support cross-functional committees and workgroups that provide governance to the regulatory assessment initiatives and processes.
  • Coordinates triaging for quality-related regulatory submissions to identify and mitigate risks and optimize assignments to disciplinary assessors.
  • Tracks and monitors workload and key performance indicators related to quality assessment activities to identify trends and areas for improvement. Develops plans and implements improvements to enhance the efficiency of regulatory processes for quality assessment activities.
  • Provides subject matter expertise to support the development of policies and procedures, the implementation of Information Technology (IT) platforms, and other initiatives related to operations and regulatory processes for quality assessment activities.

Office Organization

  • Division of Regulatory & Business Process Management I
  • Division of Regulatory & Business Process Management II
  • Division of Regulatory & Business Process Management III
  • Division of Regulatory & Business Process Management IV

Resources




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