Making Comments Count for High-Impact Regulations and Guidelines in Canada, EU, Japan, and US Chairperson: Amy N. Grant Director, Regulatory Strategy & Science ViroPharma Incorporated Insert your logo in this area then delete this text box.

46 th Annual Meeting Washington, DC Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2

46 th Annual Meeting Washington, DC Objectives Make comments count in areas of highest impact Review key commenting processes in EU, US, Canada, Japan, and other countries Compare Agency responses to comments and outcomes on the same topic including local and global considerations Apply commenting process from various perspectives: government, industry, trade association, and patient advocacy groups

46 th Annual Meeting Washington, DC Why Comment? So What about Guidance? Our regulatory world is very complex Regulations at a high level Need more detailed interpretation but want flexibility to evolve with science and technology changes The US Regulator’s Decision- Making Context (PDF - 91KB)The US Regulator’s Decision- Making Context (PDF - 91KB), April 20, 2010, Janet Woodcock, M.D.

46 th Annual Meeting Washington, DC Speakers Merete Schmiegelow, MPharm, MSc Director, Regulatory Intelligence Novo Nordisk A/S How Do you Ensure Impact on EU Regulations and Guidelines? Virginia Beakes-Read, BSN,JD Executive Director, Regulatory Policy and Intelligence Eisai, Inc. Regulatory Impact of Commenting in the US Linda F Bowen, MS,RAC Director, Regulatory Intelligence and Policy sanofi-aventis Regulatory Impact of the Consultation Procedure in Canada, Japan, and Other Countries Question & Answer Session with Panel