OSIS Workshop: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
July 19 - 20, 2022
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.
- 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
- 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.
This activity is intended for physicians, pharmacists, and nurses.
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 |
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 |
![Jointly Accredited Provider](https://ceportal.fda.gov//files/content/docs/logo-joint-accreditation-provider.png)
![ICPE Credit](https://ceportal.fda.gov//files/content/docs/icpeCreditLogo.png)
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.
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.
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
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 80% of the activity.