The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 11, 2014 from 10am to 11:30am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: clinical
Organized By: ComplianceOnline
Latest Activity: Feb 19, 2014
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:
Who Will Benefit:
This webinar will provide valuable assistance to the following personnel:
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.
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