DIA 48th Annual Meeting
Click here to go to the previous page
Clinical Trial Disclosures: A US and EU Regulatory Update
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
314
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Barbara Godlew, The FAIRE Company, LLC, United States
PRESENTER
(S):
Tracy Beck, Eli Lilly and Company, United States Rebecca Williams, National Library of Medicine, NIH, United States
Hans-Georg Eichler, European Medicines Agency, United Kingdom
Description
This session focuses on US and EU requirements for clinical trial disclosures. Information obtained during this session will include results reporting as it applies to regulatory, clinical operations, medical writing, and other related areas.
Learning Objectives:
Discuss current and future requirements of FDAAA Section 801 and EU regulations
Recognize challenges faced by regulators, academia, and industry in clinical trial disclosure activities
Discuss the impact of disclosure regulations on organizational operations and systems.
Learning Objectives:
Discuss current and future requirements of FDAAA Section 801 and EU regulations
Recognize challenges faced by regulators, academia, and industry in clinical trial disclosure activities
Discuss the impact of disclosure regulations on organizational operations and systems.
This session is a part of:
Handout Online
