DIA 48th Annual Meeting
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Hot Topics in Clinical Trial Disclosure (CTD)
Track : Track 19: SIAC Showcase
Program Code: 276
Date: Tuesday, June 26, 2012
Time: 3:30 PM to 4:30 PM  EST
CHAIR :
 Robert Paarlberg, Paarlberg & Associates LLC, United States
PRESENTER (S):
 John McKenney, SEC Associates, Inc., United States
 Merete Joergensen, Novo Nordisk A/S, Denmark
Description
This showcase will discuss the ever changing clinical trial disclosure (CTD) landscape, the impact on industry, and how companies change their processes to maximize efficiencies to meet the increasing demands of global CTD requirements. Emerging CTD requirements in selected countries will be highlighted. The showcase will also focus on results disclosure in the EU as well as discuss the challenges and complexities companies face in meeting global CTD requirements. An update will be provided on the status of NLM's Notice of Proposed Rulemaking. In addition, the audience will be encouraged to share their organizations' perspectives on these issues and how they are meeting the challenges of clinical trial disclosure. Benefits of participating in the SIAC will also be discussed. Developed by the Clinical Trial Disclosure (CTD) SIAC.

Learning Objectives:
Describe the most recent disclosure developments in the EU, US and other countries/regions
Discuss results disclosure in the EU and challenges for companies
Explain the benefits of participating in the CTD SIAC.


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