Meeting Presentations:

Day 1

• Welcome, Introductions, and Meeting Objectives by Judith Kramer, CTTI
• SAE Project Overview by Jose Vega, Amgen
• Current Practices – Workstream 1 Summary of Findings by Sundeep Sethi, Amgen
• Investigator Time and Perceived Value – Workstream 2 Summary of Findings by Howard Greenberg, ACCP
• Comparison of Alternative Models – Workstream 3 Summary of Findings by Lynda Szczech, Duke University
• Patient Perspectives – Workstream 4 Summary of Findings by Kevin Weinfurt, Duke University
• Summary of Findings from All Workstreams and Goal for October 4th Meeting by Judith Kramer, CTTI

Day 2

• Recap of Important Findings and Recommendations from Workstreams 1–4 by Judith Kramer, CTTI
• Highlights of New FDA Rule on Premarketing Safety Reporting Issued on September 28, 2010 by Janet Norden, Office of Medical Policy, CDER, FDA

Meeting Results:

On September 29, 2010—just prior to the expert meeting—the FDA issued a new final rule and accompanying draft guidance concerning IND safety reporting. The requirements of the new safety rule, which went into effect on March 28, 2011, affected interpretation of the project findings described above. Meeting participants acknowledged that the new FDA rule marked a major step forward in recognizing that little knowledge can be gained from an individual event. Participants also agreed that inundating investigators with such data is inefficient and ineffective and that the FDA rule and guidance hold promise for helping to eliminate this burden on investigators. The discussion revealed, however, that implementation of the rule could pose challenges that may only be resolved through the concerted educational efforts and international harmonization of regulatory expectations.