This training is focused on presenting an overview of how FDA’s Center for Drug Evaluation and Research approaches different issues in bioanalysis. The audience will gain a deeper and broader understanding of how bioanalysis must be performed to adequately support regulated activities and how FDA performs bioanalysis to further the agency’s mission and support regulated industry. Attendees will have the opportunity to learn firsthand how the offices that review and conduct bioanalysis conduct their work in this field.

Featured Topics:

  • Bioanalytical method validation: history, process, and regulatory perspectives
  • Regulated bioanalysis for large molecules
  • Regulated bioanalysis for small molecules
  • Biosimilars
  • Drugs and biologics
  • Bioanalysis of unstable analytes
  • Repeat analysis
  • Endogenous compound bioanalysis
  • Overview of immunogenicity inspections
  • Considerations on ex vivo conversion of prodrugs during bioanalysis
  • Bioanalysis of the dried blood spot (DBS) by mass spectrometry for the FDA regulated clinical studies
  • What meta-analysis can tell you about the performance of bioanalytical methods
  • Office of Study Integrity and Surveillance’s (OSIS) Collaboration, Risk Evaluation and Surveillance Team (CREST) Site Selection Model Overview
  • Case study: bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection

Gain a better overall understanding of FDA’s requirements and processes for reviewing studies supported by regulated bioanalysis including:

  • Describe the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
  • Describe the Office of Clinical Pharmacology’s expectations for 505b2 applications.
  • Explain the Office of Generic Drug’s Office of Bioequivalence documentation needs for bioanalysis used in bioequivalence studies.
  • Understand how the Office of Testing and Research develops bioanalytical methods.
  • Participate in a workshop that will engage attendees to work through an example case study in bioanalysis regulation.

This event is intended for:

  • Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data
  • Researchers involved in regulated bioanalysis
  • Sponsors planning studies involving bioanalysis
  • Industry professionals associated analytical laboratories that involve bioanalysis

FDA Resources:

This course:

  • has been pre-approved by SOCRA who accepts documentation of candidate participation 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.
  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • 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.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
  • Real-time attendance is required for the certificate of attendance. Certificates are only available during the two weeks post-event.

Please contact for all technical questions.