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Recent clinical trial transparency regulations have been developed to provide greater access to clinical trial information. As a result, the pharmaceutical industry is changing its approach to responsibly sharing the results of clinical trials and addressing what information needs to be released, when and how, in order to comply with these recent regulations. This short course will focus on the European Medicine Agency’s (EMA) Publication Policy 0070 and the US Department of Health and Human Services (HHS) Final Rule for Section 801 of the US Food and Drug Administration Amendments Act (FDAAA) of 2007. We will discuss how these recent US and EU regulations related to data disclosure are being implemented and will also focus on the application of preparing such documents for disclosure.
Who should attend?
This short course is designed for medical writers who will be preparing documents for disclosure.
At the conclusion of this course, participants should be able to:
Define what is in scope, the timing, and requirements of the EMA Policy 0070 and HHS Final Rule
Discuss how regulatory documents can be prepared for disclosure
Apply best practices in developing layperson summaries
Discuss the impact of clinical trial disclosure regulations and initiatives on publication deliverables