Regulatory and Operational Considerations for Biorepositories

Tuesday, August 9, 2016 - 2:00pm to 3:00pm

More and more research includes the use of biorepositories, however the creation and use of biorepositories can pose regulatory and operational challenges, especially in the face of a possibly changing regulatory landscape. This webinar will address the following topics:

  • Repository models
  • Repository management considerations
  • Regulatory considerations (HHS, FDA, HIPAA)
  • Informed Consent
  • Potential implications from the Common Rule Notice of Proposed Rulemaking (NPRM) 

Learning Objectives:

  • Identify different biorepository models
  • Understand the impact of different regulations on biorepositories

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Madeleine Williams, MA, CIP, Senior Director, Huron Consulting Group
Phil Cola, PhD, Vice President, Research and Technology, University Hospitals Case Medical Center
Knowledge level: 
Individual registration
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