DRAFT

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

RESEARCH REVIEW SUBCOMMITTEE OF THE

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

OFFICE SITE VISIT

OFFICE OF VACCINES RESEARCH AND REVIEW

 

May 19, 2006

Hilton Hotel, Washington DC North/Gaithersburg,

620 Perry Parkway, Gaithersburg, MD  20877

 

AGENDA

 

Open Committee Discussion

 

8:00 a.m.         Welcome and Introduction of Committee

Walter Royal, M.D., Chair

 

8:10                 Conflict of Interest Statement

                                    Christine Walsh, R.N., Executive Secretary

 

8:15                 Introduction/Charge to Committee

            Jesse L. Goodman, M.D., M.P.H.

            Director, Center for Biologics Evaluation and Research

                        CBER Mission

                        CBER Program Structure

 

8:35                 Overview of CBER Research Programs

                                    Kathryn Carbone, M.D.

                                    Associate Director for Research, CBER

 

9:00                 Overview of the Office of Vaccines Research and Review (OVRR)

Norman Baylor, Ph.D., Director

                        Office Mission and Structure

                        Regulatory Activities and Priorities

                        Research Program Introduction

 

9:30                 Q & A

 

9:50 a.m.         Break

 

Research Review Subcommittee of the

Vaccines and Related Biological Products Advisory Committee

Site Visit Review

Office of Vaccines Research and Review

May 19, 2006

 

 

AGENDA (Cont’d)

 

            Open Committee Discussion

 

 

10:05 a.m.       Office of Vaccines Research and Review Research Program

Michael Brennan, Ph.D., Associate Director of Research, OVRR

                                    Research Management, Accomplishments and Future Plans

 

10:40 a.m.       Overview of the Division of Viral Products

                                    Jerry Weir, Ph.D., Director DVP

Mission/Philosophy/Regulatory Activities and 

Public Health Impact

                                                Regulatory and Research Expertise

Research Program Structure and Research

                                                Activities and Priorities

                                               

 

11:15 a.m.       Overview of the Division of Bacterial Parasitic and Allergenic Products

                                    Richard Walker, Ph.D., Director DBPAP

Mission/Philosophy/Regulatory Activities and 

Public Health Impact

                                                Regulatory and Research Expertise

Research Program Structure and Research

                                                Activities and Priorities

 

11:45 a.m.       Q&A

 

12:00 p.m.       Open Public Hearing

 

1:00 p.m.         Adjourn Open Session/Lunch

 

 

2:00 p.m.         Closed Committee Discussion

 

4:30 p.m.         Adjourn Closed Session                      

 

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