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  1. Vaccines, Blood & Biologics

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