Record of Telephone Conversation - Agriflu, November 17, 2008

System Info - 107020 MCWATTERS, BERNARD 06-Oct-2009 15:41:25 MCWATTERS

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125297/0 Office: OVRR

Product:
Influenza Vaccine

Applicant:
Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 17-NOV-2008 12:00 AM
Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Other

Author: BERNARD MCWATTERS

Telecon Summary:
Response to question about the clinical investigator at one of the Dominican Republic sites

FDA Participants: Bernard McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear JP,
We confirm that the original investigator study documentation is maintained for both sites by the investigator staff at site 10. There is no mention of the Ethics Committee destroying all their original documentation in our memo to you dated October 17th. We apologize if there has been any misunderstanding in this regard.

Kind regards,
Joanne Totosy de Zepetnek, PhD
Vaccine Regulatory Affairs - North America
Novartis Vaccines and Diagnostics, Inc.
Tel: (617) 871-7929 / +39 0577 24 3288
Mobile: (617) 460-2376
Email: joanne.totosy@novartis.com