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Session 5 Track D: Innovations in Sharing of Clinical Trial Results
Session Chair(s)
Eileen Girten, MS
Medical Writing Therapeutic Area Lead
Pfizer, United States
In November 2014, a Notice of Proposed Rule Making was published by the US Department of Health and Human Services for Section 801 of the US Food and Drug Administration and Amendments Act of 2007 (FDAAA) and proposes to expand the types of clinical trials that require registration and reporting of results to ClinicalTrials.gov. The final rule is expected to be published in 2016. In this session, we will discuss what the current law and the proposed changes, if implemented, means for medical writers?
Learning Objective : - Describe the proposed changes to Section 801 of FDAAA
- Discuss some of the public comments in response to the NPRM
- Recall current experiences with results reporting from the ClinicalTrials.gov perspective
- Discuss helpful hints and best practices to medical writers involved in clinical trial disclosure
Speaker(s)
Reporting Results to ClinicalTrials.gov and Changes Proposed in Rule Making
Rebecca Williams, PHARMD, MPH
Essex, part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
Reporting Results to ClinicalTrials.gov and Changes Proposed in Rulemaking
Helle Gawrylewski, MA
Hawkwood Consulting, LLC, United States
Owner