DIA 48th Annual Meeting
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New Regulations and Guidance for Clinical Trials and Human Subject Protection
Track
:
Track 01: Clinical Operations
Program Code:
348
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Cynthia Gates, Western Institutional Review Board, United States
PRESENTER
(S):
Cynthia Gates, Western Institutional Review Board, United States Nancy Meyerson-Hess, Gruenenthal, Germany Michael Roach, Meade and Roach, LLP, United States
Description
This session will cover recent changes to regulations and guidances as well as proposed changes by the Office for Human Research Protections (OHRP) and FDA. Attendees will learn how the changes might affect their day-to-day workflow, how to identify compliance gaps and how to correct the gaps.
Learning Objectives:
Describe the effect the changes and proposed changes in regulations and guidance will have on clinical trial procedures
Identify gaps in compliance resulting from the changes
Discuss how to implement process changes to comply with the changes.
Learning Objectives:
Describe the effect the changes and proposed changes in regulations and guidance will have on clinical trial procedures
Identify gaps in compliance resulting from the changes
Discuss how to implement process changes to comply with the changes.
This session is a part of:
Handout Online
