
Employee Officer EDR Memo, September 11, 2013 - Q-Pan



 


To:                              The File

Date:                           

 

BLA:                             STN 125419 September 11, 2013/0               

Sponsor:                         ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)

Product:                         Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

 

From:                            Carmen Collazo-Custodio, PhD

Signature:                   

 

 

 

Section 916 of the Food and Drug Administration Amendments Act (FDAAA) requires that the identity of each employee or officer who participated in the decision to approve an original application be listed and filed as part of the Action Package for that file.

 

The following employees and officers have consented to have their names published publicly as being a participant in the approval decision for this file.

 

Committee Member                                     Review Assignment

Carmen Collazo-Custodio                              Chair                                          

Jeremy Wally                                         Lead RPM                                   

Kirk Prutzman                                        Co-RPM                                     

Hana Golding                                         Product CMC                            

Surender Khurana                                     Product CMC                             

Nabil Al-Humadi                                      Toxicology                                 

Tielin Qin                                           Assays Stats                               

Cheryl Hulme                                         Lot Release                                                

Anthony Hawkins                                      BIMO                                         

Randa Melhem                                         Facilities/DMPQ                        

James Kenney                                         Product Quality                         

Lokesh Bhattacharyya                                 Product Quality                         

Karen Campbell                                       Product Quality                         

David Schwab                                         Electronic Integrity Review