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DTSTART:19700308T020000
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UID:2140535:Event:63431
DTSTAMP:20260521T150834Z
SUMMARY:When Studies are Exempted from IND Requirements: Understanding
  the Criteria and the Consequences
DESCRIPTION:This Clinical compliance training will review the purpose 
 of INDs and the process for obtaining an IND. Attendees will gain a co
 mplete understanding of the criteria for exemption and the impact an e
 xemption has on a study.\n\nWhy Should You Attend:\nDo you understand 
 when an IND Exemption may be granted? Do you understand the applicatio
 n process and timeline for the exemption? Do you understand how a stud
 y, or future use of data collected in a study, exempted from an IND ma
 y be impacted?\nIf you do not know the answer to one or more of these 
 questions attending this one-hour webinar will help you to be better i
 nformed about IND exemptions.\nThis session will briefly review the pu
 rpose of INDs and the process for obtaining an IND. It will explore th
 e circumstances and cases that allow a study to be granted an IND exem
 ption 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. Fina
 lly, if an exemption is appropriate, this training will help attendees
  make sure they understand how to secure the correct approvals, and th
 e timeline for the process.\nLearning Objective:\nAt the end of this w
 ebinar, participants will understand criteria for exemption and be abl
 e to describe the impact an exemption has on a study.\nAreas Covered i
 n the Webinar:\n\nReview of purpose and process of IND applications.\n
 Understand exceptions to the IND requirement.\nProcess of exemption re
 quest.\nLimitations of research carried out under an exemption.\nFutur
 e Data Use restrictions.\nHow to decide if a request for exemption is 
 prudent.\n\nWho Will Benefit:\nThis webinar will provide valuable assi
 stance to the following personnel:\n\nInvestigators\nCoordinators\nReg
 ulatory Specialists\nIndustry Sponsors involved in Investigator Initia
 ted Research\nCompliance Officers\nIRB members\n\nInstructor Profile:\
 nJennifer Holcomb, MA, CCRC, is a clinical research professional with
  over 20 years of experience in the field. Currently employed by UC He
 alth Systems, (jennifer.holcomb@uchealth.org), she provides guidance a
 nd leadership in the establishment and development of policies in the 
 conduct and management of clinical research. Key areas of expertise in
 clude clinical trial budgeting and contract negotiations as well as re
 gulatory knowledge including international ICH GCP standards. Jennifer
  has extensive experience in training and education and complete a 4 y
 ear term as Vice Chair of the ACRP Professional Development Committee 
 in December of 2013.\n\nFor more information visit https://medtechiq.n
 ing.com/events/when-studies-are-exempted-from-ind-requirements-underst
 anding-the
DTSTART;TZID=America/New_York:20140311T100000
DTEND;TZID=America/New_York:20140311T113000
CATEGORIES:clinical
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702345?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702345?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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