ComplianceOnline

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

Instructor: Jennifer Holcomb 
Product ID: 702345
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2016

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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:

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

Instructor Profile:

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Currently employed by UC Health Systems, (jennifer.holcomb@uchealth.org), 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 complete a 4 year term as Vice Chair of the ACRP Professional Development Committee in December of 2013.

Topic Background:

While most Clinical Research Professionals understand the role of an IND when a new compound is being developed, there is often confusion around the need of an IND when an “off-label” use of a product is being considered for evaluation or when two marketed compounds are being considered for comparison. Regulations outline when an IND is required and conditions when a study may be exempted from the requirement. However, when seeking an exemption it is important to understand the limitations this may place on the study or future use of the data.

Follow us :
Project Management in Human Resources - 80334SEM
Computer System Validation - Reduce Costs and Avoid 483s

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading