U.S. Food and Drug Administration | REdI Annual Conference 2024: CBER (Biologics) Innovation in Medical Product Development (Day 2 of 2) @US_FDA | Uploaded 4 months ago | Updated 10 hours ago
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.
6:07 CBER Track Day 2 Welcome – Larissa Lapteva, MD, MHS, MBA
12:52 Session 1: Introduction of Hector S. Izurieta, MD, MPH, PhD
14:26 Use of Real-World Evidence in Accelerated Approval - Hector S. Izurieta, MD, MPH, PhD
32:56 Session 1: Introduction of Peter J. Weina, PhD, MD
34:36 Artificial Intelligence Challenges for Regulating Vaccine Development - Peter J. Weina, PhD, MD
57:01 Session 1: Introduction of Sudhakar Agnihothram, BPharm, PhD
58:14 CBER’s Advanced Manufacturing Programs for Sponsors - Sudhakar Agnihothram, BPharm, PhD
1:27:19 Q&A with Session 4 Speakers
2:04:58 Introduction of Session 5 – Larissa Lapteva, MD, MHS, MBA
2:05:55 Session 5: Introduction of Meghna Alimchandani, MD
2:07:02 Postmarketing Surveillance for Product Safety in Pregnancy - Meghna Alimchandani, MD
2:45:47 Session 5: Introduction of Craig Zinderman, MD, MPH
2:47:11 Update on the ICH E2D(R1) Guideline: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs) - Craig Zinderman, MD, MPH
3:23:57 Q&A with Session 5 Speakers
4:34:35 Introduction of Session 6 - Melek Sunay, PhD
4:35:04 Session 6: Introduction of Orieji Illoh, MD
4:36:10 Blood Regulation and Safety - Orieji Illoh, MD
5:07:52 Session 6: Introduction of Julia Tait Lathrop, PhD
5:09:03 FDA Regulation of HIV Tests - Julia Tait Lathrop, PhD
5:43:51 Q&A with Session 6 Speakers
6:19:35 Introduction of Session 7 – Larissa Lapteva, MD, MHS, MBA
6:20:13 Session 7: Introduction of Triet M. Tran, PharmD, BCSCP
6:21:19 The Center for Biologics Evaluation and Research (CBER) Bioresearch Monitoring Program - Triet M. Tran, PharmD, BCSCP
6:53:36 Session 7: Introduction of Seth Schulte, MS
6:54:37 CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods - Seth Schulte, MS
7:26:43 Q&A with Session 7 Speakers
7:37:56 CBER Track Closing Remarks
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.
6:07 CBER Track Day 2 Welcome – Larissa Lapteva, MD, MHS, MBA
12:52 Session 1: Introduction of Hector S. Izurieta, MD, MPH, PhD
14:26 Use of Real-World Evidence in Accelerated Approval - Hector S. Izurieta, MD, MPH, PhD
32:56 Session 1: Introduction of Peter J. Weina, PhD, MD
34:36 Artificial Intelligence Challenges for Regulating Vaccine Development - Peter J. Weina, PhD, MD
57:01 Session 1: Introduction of Sudhakar Agnihothram, BPharm, PhD
58:14 CBER’s Advanced Manufacturing Programs for Sponsors - Sudhakar Agnihothram, BPharm, PhD
1:27:19 Q&A with Session 4 Speakers
2:04:58 Introduction of Session 5 – Larissa Lapteva, MD, MHS, MBA
2:05:55 Session 5: Introduction of Meghna Alimchandani, MD
2:07:02 Postmarketing Surveillance for Product Safety in Pregnancy - Meghna Alimchandani, MD
2:45:47 Session 5: Introduction of Craig Zinderman, MD, MPH
2:47:11 Update on the ICH E2D(R1) Guideline: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs) - Craig Zinderman, MD, MPH
3:23:57 Q&A with Session 5 Speakers
4:34:35 Introduction of Session 6 - Melek Sunay, PhD
4:35:04 Session 6: Introduction of Orieji Illoh, MD
4:36:10 Blood Regulation and Safety - Orieji Illoh, MD
5:07:52 Session 6: Introduction of Julia Tait Lathrop, PhD
5:09:03 FDA Regulation of HIV Tests - Julia Tait Lathrop, PhD
5:43:51 Q&A with Session 6 Speakers
6:19:35 Introduction of Session 7 – Larissa Lapteva, MD, MHS, MBA
6:20:13 Session 7: Introduction of Triet M. Tran, PharmD, BCSCP
6:21:19 The Center for Biologics Evaluation and Research (CBER) Bioresearch Monitoring Program - Triet M. Tran, PharmD, BCSCP
6:53:36 Session 7: Introduction of Seth Schulte, MS
6:54:37 CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods - Seth Schulte, MS
7:26:43 Q&A with Session 7 Speakers
7:37:56 CBER Track Closing Remarks
