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When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

 
  June 27, 2012  
     
 
ComplianceOnline, Online Event
2012-07-12


Why Should You Attend:

Do you understand when an IND Exemption may be granted? Do you understand the application process and timeline for the exemption? Do you understand how a study, or future use of data collected in a study, exempted from an IND may be impacted?

If you do not know the answer to one or more of these questions attending this one-hour webinar will help you to be better informed about IND exemptions.

This session will briefly review the purpose of INDs and the process for obtaining an IND. We will explore the circumstances and cases that allow a study to be granted an IND exemption from the FDA.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

  • Investigators
  • Coordinators
  • Regulatory Specialists
  • Industry Sponsors involved in Investigator Initiated Research
  • Compliance Officers
  • IRB members

 

 
 
Organized by: Complianceonline
Invited Speakers: Jennifer Holcomb, MA, CCRC, is a clinical research professional with 20 years of experience in the field. Currently employed by Duke University (Jennifer.holcomb@dm.duke.edu ), she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards.  Jennifer has extensive experience in training and education and serves as Vice Chair of the ACRP Professional Development Committee.
 
Deadline for Abstracts: 2012-07-11
 
Registration:

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702345?channel=hummolgen

E-mail: referral@complianceonline.com
 
   
 
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