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

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Mar 11, 2014 10:00 AM
  • End Time:
  • Tuesday - Mar 11, 2014 11:00 AM
  • Location:
  • Online
  • This Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.

    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. It will explore the circumstances and cases that allow a study to be granted an IND exemption from the FDA. The discussion will center on the pros and cons of requesting an exemption. Understanding what limitations exist when a study is exempt from an IND will help attendees to make more informed decisions about whether seeking an exemption is the right choice. Finally, if an exemption is appropriate, this training will help attendees make sure they understand how to secure the correct approvals, and the timeline for the process.

    Learning Objective:
    At the end of this webinar, participants will understand criteria for exemption and be able to describe the impact an exemption has on a study.

    Areas Covered in the Webinar:
    -Review of purpose and process of IND applications.
    -Understand exceptions to the IND requirement.
    -Process of exemption request.
    -Limitations of research carried out under an exemption.
    -Future Data Use restrictions.
    -How to decide if a request for exemption is prudent.

    Who Will Benefit:
    This webinar will provide valuable assistance to the following personnel:
    -Regulatory Specialists
    -Industry Sponsors involved in Investigator Initiated Research
    -Compliance Officers
    -IRB members
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