Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Final Agenda
July 15-16, 2019
AGENDA
Day 1, Session 1: Elements of Submission Review | Presenter | |
---|---|---|
8:00-8:05 | Introduction | Julia Lathrop, PhD DETTD/OBRR |
8:05-8:15 | Welcome | Nicole Verdun, MD OBRR |
8:15-8:45 | Overview of the Office of Blood Research and Review Device Regulation | Anne Eder, MD, PhD OBRR |
8:45-9:15 | The PreSubmission | Iwona Fijalkowska, PhD DETTD/OBRR |
9:15-9:45 | Investigational Applications in OBRR | Caren Chancey, PhD DETTD/OBRR |
9:45-10:00 | Break | |
10:00-10:45 | Chemistry, Manufacturing and Controls: Perspectives from OBRR and OCBQ |
Rana Nagarkatti, PhD DETTD/OBRR Lori Peters, MS DMPQ/OCBQ |
10:45-11:10 | Software and Instrumentation Review and Cybersecurity Considerations | Lisa Simone, PhD DETTD/OBRR |
11:10-11:25 | CLIA Categorization Processes | Peter Tobin, PhD DPOM/OPEQ/OIR/CDRH |
11:25-11:45 | Q&A with Morning Speakers | |
11:45–12:30 | Lunch | |
12:30–12:50 | Lot Release Program | Kori Francis DBSQC/OCBQ |
12:50-1:10 | An Overview of CBER Bioresearch Monitoring | Bhanu Kannan, MSc DIS/OCBQ |
1:10-1:40 | In Vitro Diagnostic Devices Inspections | Nicole Li DMPQ/OCBQ |
1:40-2:00 | Biological Product Deviation Reporting for CBER Licensed IVD Devices Medical Device Reporting for CBER IVD Devices |
Sharon O’Callaghan, BS, MT(ASCP) Bima Patel, BS,MT(ASCP) DMPQ/OCBQ |
2:00–2:30 | Q&A for Session 1 with all speakers | |
2:30–2:45 | Break | |
Day 1, Session 2: Devices Used for Screening for Infectious Diseases in Blood and Plasma Donations | ||
2:25-2:55 | Division of Emerging and Transfusion Transmitted Diseases- Overview | J. Peyton Hobson, PhD DETTD/OBRR |
2:55-3:25 | Overview of Analytical Validation of Donor Screening Tests | Krishna Ketha, PhD DETTD/OBRR |
3:25-3:45 | Overview of Clinical Review of Donor Screening Tests | Babita Mahajan, PhD DETTD/OBRR |
3:45-4:05 | Overview of Labeling Claims for Donor Screening Tests Using Cadaveric Blood Specimens | Brychan Clark, MD DHT/OTAT |
4:05-5:00 | DETTD: Sponsor 1:1 Meetings (Preregistration required) | DETTD |
Day 2, Session 3: IVDs Regulated by the Division of Blood and Component Devices | ||
8:30-8:45 | Brief Introduction to Devices in DBCD | Wendy Paul, MD DBCD/OBRR |
8:45-9:25 | Licensed Immunohematology Products and Associated Instrumentation (Part I) | Kimberly Bigler, MLS(ASCP)CMSBB DBCD/OBRR |
9:25-10:05 | Licensed Immunohematology Products and Associated Instrumentation (Part II) | Annette Ragosta, MT(ASCP)SBB DBCD/OBRR |
10:05-10:25 | Break | |
10:25-11:05 | Molecular-Based Devices (HEA, HLA, HNA and HPA) | Zhugong "Jason" Liu, PhD DRB/DBCD |
11:05-12:00 | Ask DBCD: Q and A for Session 3 | DBCD |