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
- Date:
- July 19 - 20, 2022
- Day1:
- - ET
- Day2:
- - ET
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Topics & Presentations Day 1 |
Speakers |
|---|---|
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Welcome & Session 1 |
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Welcome by Office of Study Integrity and Surveillance (OSIS) |
Sean Kassim, PhD |
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Keynote |
ShaAvhrée Buckman-Garner, MD, PhD |
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OSIS - Introduction, Mission, Vision |
Tahseen Mirza, PhD |
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Good Laboratory Practice (GLP) 101 - Regulation and Basic Studies |
Zhou Chen, MD, PhD |
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GLP Compliance Program |
Erin McDowell |
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Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies Compliance Program |
Lynda Lanning, DVM, DABT |
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GLP Related Guidance Update: Pathology Peer Review and Whole Slide Imaging |
Lynda Lanning, DVM, DABT |
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Session One Questions & Answer Panel |
Sean Kassim, Tahseen Mirza, Zhou Chen, Erin McDowell, Lynda Lanning |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 2 |
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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 |
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In Vitro BE Studies
|
Monica Javidnia, PhD |
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Immunogenicity
|
Kara Scheibner, PhD |
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Session Two Questions & Answer Panel |
Yiyue (Cynthia) Zhang, Monica Javidnia and Kara Scheibner |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 3 |
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Inspecting Clinical BA/BE Studies
|
Xingfang Li, MD, RAC |
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Inspecting BE Studies with Clinical Endpoints
|
Xikui Chen, PhD |
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Overview of Reserve Samples
|
Li-Hong Yeh, PhD |
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Session Three Questions & Answer Panel |
Xingfang Li, Xikui Chen, and Li-Hong Yeh |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Session 4 & Closing |
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In Vivo Studies
|
Gopa Biswas, PhD |
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In Vitro Studies
|
Sripal Mada, PhD |
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Immunogenicity Studies
|
Kara Scheibner, PhD |
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Session Four Questions & Answer Panel |
Gopa Biswas, Sripal Mada, and Kara Scheibner |
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Day One Closing
|
Brian Folian, MS, JD |
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Topics & Presentations Day 2 |
Speakers |
|---|---|
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 1 |
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GLP Case Study |
Lynda Lanning, DVM, DABT Zhou Chen, MD, PhD |
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Question & Answer |
Lynda Lanning and Zhou Chen |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 2 |
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Animal Rule Case Study |
Lynda Lanning, DVM, DABT Yiyue (Cynthia) Zhang, PhD, RAC |
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Question & Answer |
Lynda Lanning and Yiyue (Cynthia) Zhang |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 3 |
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Clinical BA/BE Case Study |
Doug Pham, PharmD, JD |
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Question & Answer |
Doug Pham |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 4 |
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Analytical BA/BE Case Study |
Sarmistha Sanyal, PhD |
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Question & Answer |
Sarmistha Sanyal |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 5 |
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In Vitro BE Case Study |
Gajendiran Mahadevan, PhD |
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Question & Answer |
Gajendiran Mahadevan |
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Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 2 – Case Study 6 & Closing |
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Immunogenicity Case Study |
Amanda Lewin, PhD |
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Day Two Closing |
Sean Kassim, PhD |
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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
- Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations