Virtual | Virtual
Event Title
Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
July 19 - 20, 2022
Event Title
Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
- Date:
- July 19 - 20, 2022
- Day1:
- Tue, Jul 19 9:00 a.m. - 04:10 p.m. ET
- Day2:
- Wed, Jul 20 9:00 a.m. - 03:20 p.m. ET
| Topics & Presentations Day 1 | Speakers |
|---|---|
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Welcome & Session 1 | |
| Welcome by Office of Study Integrity and Surveillance (OSIS) | Sean Kassim, PhD Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) |CDER |
| Keynote | ShaAvhrée Buckman-Garner, MD, PhD Director Office of Translational Sciences (OTS) | CDER |
| OSIS - Introduction, Mission, Vision | Tahseen Mirza, PhD Associate Director for Regulatory Affairs OSIS | OTS | CDER |
| Good Laboratory Practice (GLP) 101 - Regulation and Basic Studies | Zhou Chen, MD, PhD Team Lead, GLP Team Division of New Drug Study Integrity (DNDSI) OSIS | OTS | CDER |
| GLP Compliance Program | Erin McDowell Biologist DNDSI | OSIS | OTS | CDER |
| Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies Compliance Program | Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER |
| GLP Related Guidance Update: Pathology Peer Review and Whole Slide Imaging | Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER |
| Session One Questions & Answer Panel | Sean Kassim, Tahseen Mirza, Zhou Chen, Erin McDowell, Lynda Lanning |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 2 | |
| Bioavailability (BA) and Bioequivalence (BE) Studies supporting NDAs under the 505(b)(2) and ANDA under the 505(j) Application Pathways | Yiyue (Cynthia) Zhang, PhD, RAC Senior Staff Fellow, BE Team DNDSI | OSIS | OTS | CDER |
| Monica Javidnia, PhD Staff Fellow, BE Team Division of Generic Drug Study Integrity (DGDSI) OSIS | OTS | CDER |
| Kara Scheibner, PhD Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER |
| Session Two Questions & Answer Panel | Yiyue (Cynthia) Zhang, Monica Javidnia and Kara Scheibner |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 3 | |
Inspecting Clinical BA/BE Studies
| Xingfang Li, MD, RAC Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER |
Inspecting BE Studies with Clinical Endpoints
| Xikui Chen, PhD Pharmacologist, BE Team DGDSI | OSIS | OTS | CDER |
| Li-Hong Yeh, PhD Interdisciplinary Scientist, BE Team DNDSI | OSIS | OTS | CDER |
| Session Three Questions & Answer Panel | Xingfang Li, Xikui Chen, and Li-Hong Yeh |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 4 & Closing | |
| Gopa Biswas, PhD Team Lead, BE Team DNDSI | OSIS | OTS | CDER |
| Sripal Mada, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER |
| Kara Scheibner, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER |
| Session Four Questions & Answer Panel | Gopa Biswas, Sripal Mada, and Kara Scheibner |
Day One Closing
| Brian Folian, MS, JD Deputy Office Director OSIS | OTS | CDER |
| Topics & Presentations Day 2 | Speakers |
|---|---|
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 1 | |
| GLP Case Study | Lynda Lanning, DVM, DABT Zhou Chen, MD, PhD |
| Question & Answer | Lynda Lanning and Zhou Chen |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 2 | |
| Animal Rule Case Study | Lynda Lanning, DVM, DABT Yiyue (Cynthia) Zhang, PhD, RAC |
| Question & Answer | Lynda Lanning and Yiyue (Cynthia) Zhang |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 3 | |
| Clinical BA/BE Case Study | Doug Pham, PharmD, JD Associate Director for Clinical Policy OSIS | OTS | CDER |
| Question & Answer | Doug Pham |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 4 | |
| Analytical BA/BE Case Study | Sarmistha Sanyal, PhD Chemist, BE Team DGDSI | OSIS | OTS | CDER |
| Question & Answer | Sarmistha Sanyal |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 5 | |
| In Vitro BE Case Study | Gajendiran Mahadevan, PhD Pharmacologist, BE Team DNDSI | OSIS | OTS | CDER |
| Question & Answer | Gajendiran Mahadevan |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 6 & Closing | |
| Immunogenicity Case Study | Amanda Lewin, PhD Team Lead, BE Team DGDSI | OSIS | OTS | CDER |
| Day Two Closing | Sean Kassim, PhD Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) |CDER |
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ABOUT THIS WORKSHOP
This workshop will:
- Describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS)
- 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
- Engage attendees to work through case studies representative of the above programs.
INTENDED AUDIENCE
- Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data
- Regulatory affairs professionals who are involved in GLP-regulated nonclinical laboratory studies and Animal Rule study data
- Researchers involved in regulated bioanalysis
- Sponsors planning studies involving bioanalysis
- Industry professionals associated analytical laboratories that involve bioanalysis
TOPICS COVERED
- Overview of Good Laboratory Practice (GLP), Animal Rule (AR), Compliance Programs (CPs) and inspections
- Guidance updates – Pathology Peer Review and Whole Slide Imaging
- OSIS BA/BE Program that includes BA Studies 505(b)2, BE studies, In Vitro BE studies and immunogenicity studies
- Expectations during BA/BE Inspections – Immunogenicity, Clinical CP, Clinical Endpoints and Analytical Studies
- Reserve sample requirements
- Case studies representing the different compliance programs.
FDA RESOURCES
- Regulations
- Related Guidance