OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice

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June 13, 2024

About This Course

The Office of Study Integrity and Surveillance (OSIS) ensures data supporting regulatory decisions are reliable by conducting and directing inspections of Bioavailability/Bioequivalence (BA/BE) and nonclinical Good Laboratory Practice (GLP) studies submitted to FDA. FDA experts will:

• Describe the Mission and Vision of OSIS.
• Discuss the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
• Provide an overview of compliance programs dealing with inspections of facilities that perform GLP, Animal Rule (AR), In Vivo Clinical BA/BE, and In Vivo Analytical BA/BE studies.
• Engage attendees to work through case studies representative of the above programs.

Intended Audience

• Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data.
• Regulatory affairs professionals who are involved in GLP-regulated nonclinical laboratory studies and Animal Rule studies data.
• Researchers involved in regulated bioanalysis.
• Sponsors planning studies involving bioanalysis.
• Industry professionals associated analytical laboratories that involve bioanalysis.

Topics Covered

• Expectations during BA/BE Inspections – Immunogenicity, Clinical, Clinical Endpoints and Analytical Clinical Programs.
• Overview of Good Laboratory Practice (GLP) /Animal Rule (AR) Compliance Programs and inspections.
• Understanding of OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies.
• Gain a better understanding of reserve sample requirements.

Resources

• Regulation Part 320 – Bioavailability and Bioequivalence Requirements
• M10 Bioanalytical Method Validation and Study Sample Analysis, 2022
• Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples, 2024
• Good Laboratory Practice for Nonclinical Laboratory Studies
• Office of Study Integrity and Surveillance Workshop Videos, July 19-20, 2022

visit the FDA.gov webpage