This is a free live Webinar hosted by SBIA/FDA Office of Study Integrity and Surveillance (OSIS).
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.
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.
This course has been pre-approved by:
- ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
- 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.