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Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?
Session Chair(s)
William Gregory, PHD
Senior Director, Safety and Risk Management, Pfizer Inc, United States
FDA has provided guidance to sponsors on systematic approaches to IND safety reporting that focus on informative reports of important safety information. To enhance the efficiency of this process, FDA has initiated a pilot program for the submission of IND safety reports in a standardized, structured format that follows the ICH E2B standard (with certain regional modifications). Likewise, for expedited clinical trial safety reports in Japan and elsewhere. This forum is designed to provide a balanced discussion of clinical trial electronic case reporting requirements based on audience interest. The forum will include lessons learned from the ongoing US pilot and a comparison with the clinical trials reporting situation in Japan. Each of the expert panel members will provide brief introductory comments and, at the conclusion of prepared remarks, the panel will entertain Q&A.
Learning Objective : Discuss the importance of providing informative IND safety reports to FDA and high-level requirements for submission of ICSRs in E2B format; Describe the benefits and challenges of implementing structured electronic safety reports from clinical trials in the US and Japan; Outline initiatives in the US and Japan to improve and streamline expedited clinical trial safety reporting.
Speaker(s)
Tamy Kim, PHARMD
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
Teiki Iwaoka, PHD, MS
Director, Pharmacovigilance, Clinical Development, Rockhill Consulting, Japan
Ta-Jen Chen, MS
Project Management Officer, OSP, CDER, FDA, United States
Suranjan De, MBA, MS
Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Dieter Kempf, MS
Group Director, PV Intelligent Automation and Business Systems Solutions, Genentech, A Member of the Roche Group, United States
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