Event Date - June 14 2011

Presented By:  Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc. and Chief Scientist and Regulatory Officer and Katarina Halling, Senior Scientific Consultant, PRO Consulting

Original Air Date: June 14, 2011

You’ve diligently planned your PRO strategy. You thought you researched and selected the most appropriate PRO instrument for your program, or maybe you developed a new one based on FDA Guidance. You’ve communicated your plans with the Division and now – FDA requests additional information or changes to your PRO-based clinical development plans.

This scenario is not uncommon. Many biopharmaceutical researchers are surprised when FDA questions their PRO-based research strategies and don’t know how to interpret or respond to specific feedback.

In this interactive webinar, Dr. Jean Paty and Katarina Halling will review some common pitfalls of PRO-based research and offer direction on adhering to regulatory guidance. They will present examples of researchers who, upon receiving feedback from FDA, took appropriate steps to revise their PRO strategies to meet regulatory scrutiny and continue in their development plans.