2006N-0464
  

  
 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC13
  



  

  
Submitter : 
  

  
Ms. nancy Smerkanich
  

  
Date & Time: 
  

  
12/11/2006 10:12:53
  



  

  
Organization : 
  

  
Octagon Research Solutions
  



  

  
Category : 
  

  
Private Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I wish to participate in the FDA Public Meeting on Electronic Submissions.

My information is as follows:

Name:  Nancy Smerkanich

Title:  Vice President, Regulatory Affairs

Business Affiliation:  Octagon Research Solutions

Address:   585 E. Swedesford Road

  Suite 200

  Wayne PA  19087

Phone:   610/535-6500 x. 5514

Fax:  610/535-6515

email: <nsmerkanich@octagonresearch.com>



I would like to address the following topics in a 15 minute presentation:

1.  Transition From Paper to Electronic

 Results of informal survey of 70+ companies

2.  Cost

 Direct cost comparison based on our operating model

3.  Time

 Direct time comparison based on our experience

4.  Implementation

 Results of informal survey of 70+ companies