| 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 |
|
In Vitro BE Studies
|
Monica Javidnia, PhD
Staff Fellow, BE Team
Division of Generic Drug Study Integrity (DGDSI)
OSIS | OTS | CDER |
|
Immunogenicity
|
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 |
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|
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 |
|
Overview of Reserve Samples
|
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 |
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|
In Vivo Studies
|
Gopa Biswas, PhD
Team Lead, BE Team
DNDSI | OSIS | OTS | CDER |
|
In Vitro Studies
|
Sripal Mada, PhD
Pharmacologist, BE Team
DNDSI | OSIS | OTS | CDER |
|
Immunogenicity Studies
|
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 |
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