Record of Telephone Conversation - Cervarix, August 6, 2008
Record of Telephone Conversation
STN Number: 125259/0
From: Helen S. Gemignani, Regulatory Project Manager
Subject: Distribution Reports
Telecon Date: 8/6/2008 Telecon Time: 3:11 pm
Telecon Initiated by: Helen S. Gemignani
Contact Phone: 610 787-3752
Summary of Telecon
The following information was conveyed to GSK in response to their request as to whether they needed to submit monthly distribution reports for Cervarix.
1. GSK can suspend monthly dose distribution reports at this time.
2. CBER would want to see dose distribution at the time of the final submission for safety updates in the post-marketing period (EU and other countries), and 2 months prior to a scheduled VRBPAC at the time of an additional safety update.
3. CBER may require doses distributed at the time of an SAE of specific interest.
End of Teleconference
- Helen Gemignani
- Matthew Whitman
- Cindy D’Ambrosia