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Clinical Research Transparency and Data Disclosure Strategies Conference



 
Our Price: $495.00

Product Code: 2272
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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.

About the Clinical Research Transparency and Data Disclosure Strategies Conference:

Understanding the Impact of Evolving Regulatory Requirements for the Disclosure of Clinical Research in the US and on an International Level, while Implementing Operational Efficiencies that Support Business Practices & Protect Patient Data & Privacy


While many companies are supportive of increasing regulatory requirements surrounding the disclosure and transparency of clinical research studies and collected data, there is mounting concern related to the impact that these disclosure initiatives will have on a wide variety of areas of the pharmaceutical and device business. In the US, corporations are looking for guidance and equal transparency from federal organizations including the FDA and ClinicalTrials.gov on what information needs to be disclosed, the most appropriate format and vehicles for this disclosure as well as timelines for release. Organizations operating on a global scale are also facing concerns surrounding increased transparency regulations in the European Union, including the EudraCT database registration and disclosure requirements. There is much to be clarified surrounding the regulatory aspects of clinical data disclosure, and the Q1 Clinical Research Transparency & Data Disclosure Conference provided a robust platform for dialogue and information exchange with a broad panel of presenters.

Of concern and a central focus for the program was operational aspects of clinical data disclosure; providing executives with practical solutions for preparing data for disclosure which can be immediately implemented, streamlining the process for complying with new regulations. With a thoroughly developed agenda covering both strategic as well as operational challenges, this conference provided executives with the tools and knowledge required to move forward with the confidence that regulatory requirements are being met while also protecting business assets.



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