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Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Draft Agenda

Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Draft Agenda

July 15th Day 1, Session 1: Elements of Submission Review Presenter
7:00-8:00 Registration  
8:00-8:05 Introduction Julia Lathrop, PhD
DETTD/OBRR
8:05-8:20 Welcome Nicole Verdun, MD
OBRR
8:20-8:50 Overview of OBRR and IVD Regulation Anne Eder, MD, PhD
OBRR
8:50-9:20 PreSubmissions Iwona Fijalkowska, PhD
DETTD/OBRR
9:20-9:50 Investigational Applications In OBRR Caren Chancey, PhD
DETTD/OBRR
9:50-10:05 Break
10:05-10:50 Chemistry, Manufacturing and Controls:
Perspectives from OBRR and OCBQ
Rana Nagarkatti, PhD
DETTD/OBRR
Lori Peters
DMPQ/OCBQ
10:50-11:10 Software Review and Cybersecurity Considerations Lisa Simone, PhD
DETTD/OBRR
11:10-11:25 CLIA Categorization Processes Peter Tobin, PhD,
DPOM/OPEQ/OIR/CDRH
11:25-11:40 Q&A  
11:40-12:30 Lunch
12:30-12:50 Lot Release Program Kori Francis, PhD
DBSQC/OCBQ
12:50-1:10 BIMO Bhanu Kannan, PhD
DIS/OCBQ
1:10-1:40 IVD Device Inspections Nicole Li
DMPQ/OCBQ
1:40-2:10 Q&A for Session 1 w/ all speakers
2:10-2:25 Break
Session 2: Devices used for screening for infectious disease in blood and plasma donations
2:25-2:40 Introduction of DETTD Donor Screening Tests J. Peyton Hobson, PhD
DETTD/OBRR
2:40-3:10 Overview of Analytical Validation of Donor Screening Tests Krishna Ketha, PhD
DETTD/OBRR
3:10-3:40 Overview of Clinical Review of Donor Screening Tests Babita Mahajan, PhD
DETTD/OBRR
3:40-4:00 Overview of Review of Cadaveric Claims Brychan Clark, MD
DHT/OTAT
4:00-5:00 DETTD: Sponsor 1:1 Meetings (Preregistration required) DETTD
July 16th Day 2, Session 3: IVDs regulated by 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 2 DBCD

 

Slides, transcript, and webcast will be posted on the CBER website following the meeting.