2004D-0117 - International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  

  



  

  
Submitter : 
  

  
Dr. Judith Sills
  

  
Date & Time: 
  

  
05/21/2004 04:05:09
  



  

  
Organization : 
  

  
Novartis Pharmaceuticals Corp.
  



  

  
Drug Industry
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 May 19, 2004







Division of Dockets Management (HFD-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852



Re: Comments on International Conference on Harmonisation; 

Draft Guidance on E2E Pharmacovigilance Planning

Published on 30 March 2004

Docket No. 2004D-0117



    

Dear Sir/Madam:



Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,200 people and operate in over 140 countries around the world.



Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. 



As one of the world?s largest pharmaceutical manufacturers, Novartis has committed extensive resources to the handling of safety information for its investigational and marketed products.  The proposals outlined in the ICH E2E draft guideline will significantly impact our global safety handling operations and we appreciate the opportunity to offer comments on this guideline.