OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
June 13, 2024
Virtual
The webinar will cover:
- The Mission and Vision of the Office of Study Integrity and Surveillance (OSIS).
- The basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
- An overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability-Bioequivalence, In Vivo Analytical Bioavailability-Bioequivalence Studies.
- Case studies representative of the above programs.
- Regulation Part 320 – Bioavailability and Bioequivalence Requirements https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.38
- M10 Bioanalytical Method Validation and Study Sample Analysis, 2022 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation-and-study-sample-analysis
- Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples, 2024 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/handling-and-retention-bioavailability-ba-and-bioequivalence-be-testing-samples
- Good Laboratory Practice for Nonclinical Laboratory Studies https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/good-laboratory-practice-nonclinical-laboratory-studies
- Office of Study Integrity and Surveillance Workshop Videos, July 19-20, 2022 https://www.fda.gov/drugs/news-events-human-drugs/office-study-integrity-and-surveillance-osis-workshop-2022-cder-inspections-good-laboratory-practice
- Describe Good Laboratory Practice (GLP) /Animal Rule (AR) Compliance Programs (CPs) and inspections
- Define the differences in the OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies
- Identify 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 Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability (BA) -Bioequivalence (BE) , In Vivo Analytical BA/BE
This activity is intended for physicians, pharmacists, and nurses.
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Day 1 June 13, 2024
Time | Topic | Speaker |
---|---|---|
8:50 - 9:00 AM EDT | SBIA Welcome, Overview and Introduction | Nora Lim, PharmD |
9:00 - 9:15 AM EDT | OSIS 101 | Tahseen Mirza, PhD |
9:15 - 9:25 AM EDT | Collaboration, Risk Evaluation, and Surveillance Program (CREST) |
Clint Mitchell, PhD Gabriel Davila, DVM |
9:25 - 9:45 AM EDT | BA/BE Analytical Program | Li-Hong Yeh, PhD |
9:45 - 9:55 AM EDT | Q&A |
Tahseen Mirza, PhD Clint Mitchell, PhD Gabriel Davila, DVM Li-Hong Yeh, PhD |
9:55 - 10:10 AM EDT | Break | |
10:10 - 10:30 AM EDT | BA/BE Clinical Program | Monica Javidnia, PhD |
10:30 - 10:50 AM EDT | GLP Program | Mark Seaton, PhD, DABT |
10:50 - 11:00 AM EDT | Q&A |
Monica Javidnia, PhD Mark Seaton, PhD, DABT |
11:00 - 11:25 AM EDT | Panel Discussion |
Kimberly Benson, PhD Seongeun Cho, PhD Arindam Dasgupta, PhD Charles Bonapace, Pharm.D. |
11:25 - 11:30 AM EDT | SBIA Closing Remarks | Nora Lim, PharmD |
All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.
Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.
Faculty
- Benson, Kimberly, PhD, Deputy Division Director, FDA/CDER/OTS/OSIS/DGDSI - nothing to disclose
- Bonapace, Charles, Pharm.D., Director, DNDSI, FDA/CDER/OTS/OSIS - nothing to disclose
- Cho, Seongeun, PhD, Director, FDA - nothing to disclose
- Dasgupta, Arindam, PhD, Deputy Division Director, CDER/OTS/OSIS/DNDSI - nothing to disclose
- Davila, Gabriel, DVM, Interdisciplinary Scientist, FDA - nothing to disclose
- Javidnia, Monica, PhD, Staff Fellow, FDA - nothing to disclose
- Lim, Nora, PharmD, Pharmacist, FDA - nothing to disclose
- Mirza, Tahseen, PhD, Associate Director for Regulatory Affairs, CDER/OTS/OSIS - nothing to disclose
- Mitchell, Clint, PhD, Lead Pharmacokineticist, FDA - nothing to disclose
- Seaton, Mark, PhD, DABT, Senior Pharmacokineticist, USFDA - nothing to disclose
- Yeh, Li-Hong, PhD, Chemist, FDA/CDER - nothing to disclose
Planning Committee
- Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Must attend 50% of the activity.