Workshop | Virtual
Event Title
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
June 13, 2024
Event Title
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
- Date:
- June 13, 2024
- Time:
- 8:50 AM - 11:25 AM ET
Attend
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ABOUT THIS EVENT
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.
FDA 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
CONTINUING EDUCATION
Registration and real-time attendance via available online rooms are required.
This event has been approved for 2.25 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information.
This course has been pre-approved by:
- RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- 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.
- SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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