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Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices

Responsible Conduct of Research Seminar Series: The webinar will provide an overview of the complex policies that govern expanded access programs involving both investigational drugs and devices. All attendees will receive 1.5 Responsible Conduct of Research contact hours. Hosted locally by Research Integrity and Human Subject Protection Program Office

What
When Sep 15, 2010
from 01:00 pm to 02:30 pm
Where IRB Conference Room - Med Center One, Suite 200
Contact Name Research Integrity
Contact Phone 852-2454
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Detail provided by PRIMR:

 

Overview

Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices, a webinar to be held on Wednesday, September 15, 2010, from 1:00 to 2:30 PM ET, will provide 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 will:

  • Broaden your understanding of expanded access programs and how they differ from clinical research
  • Explore the ethical and regulatory implications of expanded access programs for IRBs, patients, healthcare providers and researchers
  • Learn how to interpret and apply investigational drug and investigational device regulations regarding expanded access
  • Advance your thinking about, and management of, these complex issues

Audience

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