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Overview

Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices, was a webinar held on Wednesday, September 15, 2010, from 1:00 to 2:30 PM ET. The webinar provided an overview of the complex policies that govern expanded access programs involving both investigational drugs and devices.

Presented by expert faculty representing both the regulatory and institutional perspectives, this webinar:

  • Broadened attendees' understanding of expanded access programs and how they differ from clinical research
  • Explored the ethical and regulatory implications of expanded access programs for IRBs, patients, healthcare providers and researchers
  • Taught how to interpret and apply investigational drug and investigational device regulations regarding expanded access
  • Advanced attendees' thinking about, and management of, these complex issues

Audience

  • HRPP Professionals
  • Institutional Officials
  • Investigators/Physicians
  • Research staff
  • IRB members and administrators

You may purchase this webinar archive by completing this form and e-mailing or faxing it back to PRIM&R at 617.423.1185.

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Questions? 
Please contact us via e-mail or telephone at 617.423.4112, ext. 18. Thank you!