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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 Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
July 19 - 20, 2022


Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description

This activity will instruct healthcare providers in the areas of technology transfer, data mining, health information technology, science and research oversight, and knowledge management within FDA.

References
  • Regulation Part 320 – Bioavailability and Bioequivalence Requirements https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.38
  • Bioanalytical Method Validation Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry
  • Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
Learning Objectives
  • Describe Good Laboratory Practice (GLP) /Animal Rule (AR) Compliance Programs (CPs) and inspections
  • Compare and contrast Pathology Peer Review and Whole Slide Imaging
  • Define the differences in the OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies
  • Prepare site for BA/BE Inspections – Immunogenicity, Clinical CP, Clinical Endpoints and Analytical
  • Summarize a better understanding of reserve sample requirements
  • Discuss case studies representing the different compliance programs.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 July 19, 2022
Time Topic Speaker
9:00 - 9:15 AM EDT Overview and CE Remarks Brenda Stodart, PharmD, MS, BCGP, RAC
9:15 - 9:20 AM EDT Agenda Overview Sean Kassim, PhD
9:20 - 9:30 AM EDT Keynote ShaAvhree Buckman-Garner, MD, PhD
9:30 - 9:45 AM EDT Office of Study Integrity and Surveillance (OSIS) - Introduction, Mission, Vision Tahseen Mirza, PhD
9:45 - 10:05 AM EDT Good Laboratory Practice (GLP) 101 - Regulation and Basic Studies Zhou Chen, PhD
10:05 - 10:25 AM EDT GLP Compliance Program Zhou Chen, PhD
10:25 - 10:45 AM EDT Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies Compliance Program Lynda Lanning, D.V.M., DABT
10:45 - 11:05 AM EDT GLP Related Guidance Update: Pathology Peer Review and Whole Slide Imaging Lynda Lanning, D.V.M., DABT
11:05 - 11:15 AM EDT Break
11:15 - 11:30 AM EDT Question and Answer Panel Session 1: Sean Kassim, PhD
Tahseen Mirza, PhD
Zhou Chen, PhD
Erin McDowell
Lynda Lanning, D.V.M., DABT
11:30 - 11:50 AM EDT Bioavailability (BA) and Bioequivalence (BE) Studies supporting NDAs under the 505(b)(2) and ANDA under the 505(j) Application Pathways Yiyue Zhang, PhD
11:50 - 12:40 PM EDT Lunch
12:40 - 1:00 PM EDT In Vitro BE Studies Monica Javidnia, PhD
1:00 - 1:20 PM EDT Immunogenicity Kara Scheibner
1:20 - 1:35 PM EDT Question and Answer Panel Yiyue Zhang, PhD
Monica Javidnia, PhD
Kara Scheibner
1:35 - 1:55 PM EDT Inspecting Clinical BA/BE Studies Xingfang Li, MD
1:55 - 2:15 PM EDT Inspecting BE Studies with Clinical Endpoints Xikui Chen, PhD
2:15 - 2:35 PM EDT Overview of Reserve samples Li-Hong Yeh, PhD
2:35 - 2:45 PM EDT Question and Answer Panel Xikui Chen, PhD
Li-Hong Yeh, PhD
Xingfang Li, MD
2:45 - 2:55 PM EDT Break
2:55 - 3:15 PM EDT In vivo studies Gopa Biswas, PhD
3:15 - 3:35 PM EDT In vitro studies Sripal Mada
3:35 - 4:05 PM EDT Question and Answer Panel Kara Scheibner
Gopa Biswas, PhD
Sripal Mada
4:05 - 4:10 PM EDT Day 1 Closing Brian Folian, JD
Day 2 July 20, 2022
Time Topic Speaker
9:00 - 9:10 AM EDT Overview and CE Remarks Brenda Stodart, PharmD, MS, BCGP, RAC
Forest Ford, PharmD, R. Ph
Renu Lal, Pharm.D.
Nora Lim, PharmD
9:10 - 10:00 AM EDT GLP Case Study Lynda Lanning, D.V.M., DABT
10:00 - 10:50 AM EDT Animal Rule Case Study Lynda Lanning, D.V.M., DABT
10:50 - 11:00 AM EDT Break
11:00 - 11:50 AM EDT Clinical BA/BE Case Study Douglas Pham, PharmD, JD
11:50 - 12:30 PM EDT Lunch
12:30 - 1:20 PM EDT Analytical BA/BE Case Study Sarmistha Sanyal, PhD
1:20 - 2:10 PM EDT In Vitro BE Case Study Gajendiran Mahadevan, PhD
2:10 - 2:20 PM EDT Break
2:20 - 3:10 PM EDT Immunogenicity Case Study Amanda Lewin, PhD
3:10 - 3:20 PM EDT Day 2 Closing Sean Kassim, PhD
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 11.25 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 11.25 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 JA0002895-0000-22-067-L04-P for 11.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 11.25 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Biswas, Gopa, PhD, Lead Pharmacologist, CDER/OTS/OSIS - nothing to disclose
  • Buckman-Garner, ShaAvhree, MD, PhD, Super Officer Director, FDA/CDER/OTS - nothing to disclose
  • Chen, Xikui, PhD, Pharmacologist, OSIS/OTS/CDER/FDA - nothing to disclose
  • Chen, Zhou, PhD, Pharmacologist, US FDA - nothing to disclose
  • Folian, Brian, JD, Deputy Office Director, CDER-OTS-Office of Study Integrity and Surveillance - nothing to disclose
  • Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
  • Javidnia, Monica, PhD, Staff Fellow, FDA - nothing to disclose
  • Kassim, Sean, PhD, Director, CDER/OTS/OSIS - nothing to disclose
  • Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
  • Lanning, Lynda, D.V.M., DABT, Senior Biologist, CDER - nothing to disclose
  • Lewin, Amanda, PhD, Lead Pharmacologist, US FDA - nothing to disclose
  • Li, Xingfang, MD, Pharmalogist, FDA - nothing to disclose
  • Lim, Nora, PharmD, Pharmacist, FDA - nothing to disclose
  • Mada, Sripal, Pharmacologist, FDA - nothing to disclose
  • Mahadevan, Gajendiran, PhD, Pharmacologist, US Food and Drug Administration - nothing to disclose
  • McDowell, Erin, Biologist, FDA - nothing to disclose
  • Mirza, Tahseen, PhD, Associate Director for Regulatory Affairs, CDER/OTS/OSIS - nothing to disclose
  • Pham, Douglas, PharmD, JD, Associate Director of Clinical Policy, FDA - nothing to disclose
  • Sanyal, Sarmistha, PhD, Chemist, FDA - nothing to disclose
  • Scheibner, Kara, Pharmacologist, FDA/CDER/OTS/OSIS - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
  • Yeh, Li-Hong, PhD, Chemist, FDA/CDER - nothing to disclose
  • Zhang, Yiyue, PhD, Senior Staff Fellow, US FDA - 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
  • Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, 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.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 80% of the activity.