
Review Committee Assignment Memorandum, May 2, 2011 - MenHibrix

 

 
 

Date:              May 2, 2011

 

To:                  125363/12 File

Review Committee

 

From:             David C. Staten, MPH, CDR, USPHS

 

Thru:             Joseph Temenak, Ph.D.

Chair, MenHibirx Review Committee Assignment Memo

 

Subject:         Review Committee Assignment

 

The following committee members has been assigned to GSK’s CR response for MenHibrix

(Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine). The action due date for this application is October 15, 2011

Review Assignment                   Committee Member                         Supervisor

Chair                               Joseph Temenak.                          Elizabeth Sutkowski
RPM                                 David Staten,                            Elizabeth Sutkowski
                                    Kirk Prutzman                            Elizabeth Sutkowski

 

Clinical Reviewer                   Meghan Ferris                            Lucia Lee
  
Product CMC/Serology                Mustafa Akkoyunlu                        Willie Vann

Product CMC                         Willie Vann                              Jay Slater

Product CMC                         Daron Freedberg                          Willie Vann

Product CMC                         Drusilla L Burns                         Jay Slater

Product CMC                         Annisa Cheung

Product CMC                         James E Keller                          Drusilla Burns
   
Product CMC                         Majid Laassri                           Konstantin Chumakov

Product CMC                         Steven A Rubin                          Konstantin Chumakov

Product CMC                         Michael Schmitt

Product CMC                         Shuang Tang                             Philip Krause

Product CMC                         Iryna Zubkova                           Iryna Zublova

Toxicology                          Steven C Kunder                         David Green

 

Product CMC                         Tina Roecklein                         Jay Slater

Facilities/DMPQ                     Sean Byrd                              Carolyn Renshaw

Advertising/

Promotional Labeling               Maryann Gallagher                       Lisa Stockbridge

Clinical Statistical Reviewer      Barbara Kransnicka                      Massie, Tammy

Assays Statistical Reviewer        Tsai-Lien Lin                           Dale Horne

Epidemiology                       Manette Niu                             Thomas Buttolph

DPQ/Lot Testing Plan               Rajesh Gupta                            Bill McCormick

DPQ/Lot Testing Plan               Karen Campbell                          Bill McCormick

Lot Release                        Joe Quander                             Jay Elterman

BiMo                               Soloman Yimam                           Patricia Holobaugh

Electronic Integrity Review       David Schwab                            Laraine Henchal

 