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Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, April 30, 2007

Record of Telephone Conversation

 STN Number: 125259/0 

Manufacturer: GlaxoSmithKline Biologicals 

Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed 

To: File 

From: Helen S. Gemignani, Regulatory Project Manager 

Subject: Bioresearch Monitoring 

Telecon Date: 30-Apr-2007 Telecon Time: 12:00pm 

Telecon Initiated by: Helen S. Gemignani 

Contact Phone: 610 787-3726 


Summary of Telecon 

I contacted Sharon Shapowal and requested GSK send additional information to the BLA in regard to the clinical investigational site 4923. End of Teleconference 

FDA Participants 

• Helen S. Gemignani 

GSK Participants 

• Sharon Shapowal, RPh

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