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US and EU Regulatory Update of Clinical Trial Disclosure
Session Chair(s)
Barbara Godlew, RN
Associate Consultant, Scientific Communications, GSC-Bio-Medicines
Eli Lilly and Company, United States
This session focuses on US and EU requirements for clinical trial disclosure, including results reporting. Information obtained during this session applies to regulatory, clinical operations, medical writing, patient advocacy and other areas.
Learning Objective : Discuss current and future requirements of FDAAA Section 801 and EU regulations; Recognize challenges faced by regulators, academia, and industry in clinical trial disclosure activities; Describe patients’ expectations about clinical trials and registries/results databases.
Speaker(s)
Panelist
Rebecca Williams, PHARMD, MPH
Essex, part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
Panelist
Fergus Sweeney, PHD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force