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