Division of Clinical Research

Office of the Vice President and Innovation

  • Oct. 16-17, 2019
  • College Park, MD or Online
  • Free and open to the public

FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.

In this era of globalization, engaging stakeholders is essential to furthering the overall commitment to pharmaceutical quality. FDA’s goal for this event is to share information and emphasize the critical role quality plays in assuring the safety and efficacy of pharmaceutical products.  

Topics Covered

  • Manufacturing and the Quality Assessment of Applications
  • Quality Beyond Application Approval
  • Emerging Technologies in Pharmaceutical Manufacturing and Design
  • Happenings in Biologics: Biosimilars and Transition Biological Products

Intended Audience

  • Regulatory affairs professionals (innovator and generic or biosimilar)
  • Manufacturing professionals (domestic and foreign; drug product and API)
  • Foreign regulators
  • Healthcare professionals interested in learning more about the FDA’s drug quality functions

Continuing Education Credits

This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. Candidate must provide documentation of participation.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.


  1. Pharmaceutical Quality Resources: www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources
  2. FDA’s Office of Pharmaceutical Qualitywww.fda.gov/about-fda/center-drug-evaluation-and-research/office-pharmaceutical-quality
  3. CDER’s Quality Initiativewww.fda.gov/about-fda/center-drug-evaluation-and-research/cders-quality-initiative
  4. Facts About the Current Good Manufacturing Practices (CGMPs)www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
  5. Report on the State of Pharmaceutical Quality, 2018: www.fda.gov/media/125001/download
Categories FDA Regulatory
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