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Session 3 Track D: Proposed Rulemaking for FDAAA Section 801
Session Chair(s)
Eileen Girten, MS
Medical Writing Therapeutic Area Lead
Pfizer, United States
In January 2015, a Notice of Proposed Rulemaking was published by the US Department of Health and Human Services relating to the registration and publication of results of clinical trials. A proposed change to the Food and Drug Administration Amendments Act of 2007 (FDAAA), if implemented, would require summary results of other trials, including the release of results of unapproved products.
Learning Objective : At the conclusion of this session, participants should be able to:
• Describe the key aspects of the proposed rulemaking for the FDAAA Section 801
• Discuss how these proposed changes will affect medical writers
• Identify challenges and discuss best practices for reporting clinical trial results
Speaker(s)
Faculty
Scott Patton
Stanford University, United States
Clinical Trials Regulatory Manager
Faculty
Barbara Godlew, RN
Eli Lilly and Company, United States
Associate Consultant, Scientific Communications, GSC-Bio-Medicines