Vaccines, Blood & Biologics
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Review Committee Assignment, July 25, 2011 - MenHibrix
Date: July 25, 2011
To: 125363/12 File
Review Committee
From: Kirk Prutzman, Ph.D.
Thru: Joseph Temenak, Ph.D. Chair, MenHibrix Review Committee Assignment Memo
Subject: Addition of Lucia Lee, M.D. to Review Committee Assignment
Lucia Lee, M.D. has been assigned to GSK’s CR response for MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) as a Clinical Reviewer.
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
RPM Kirk Prutzman Elizabeth Sutkowski
Clinical Reviewer Meghan Ferris Lucia Lee
Clinical Reviewer Lucia Lee Douglas Pratt
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
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 Dale Horne
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
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