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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
June 13, 2024
Virtual

Activity Coordinators:
Matthew Palumbo (Matthew.Palumbo@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov),  Forest Ford (Forest.Ford@fda.hhs.gov),  Renu Lal (Renu.Lal@fda.hhs.gov),  Nora Lim (Nora.Lim@fda.hhs.gov)
Description

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.

References
  • 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
Learning Objectives
  • 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
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Registration Information
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.
Agenda
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
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 2.25 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 2.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-071-L99-P for 2.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 2.25 contact hour(s).
Requirements for Receiving CE Credit

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.

Disclosure

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
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Requirements for Certificate of Completion (Non CE)
Must attend 50% of the activity.