Institute for International Research

Dear Colleague,

Welcome to IIR's 10th Annual "Implementing E-Submissions: An Investment for Expediting Drug Approval" conference. In the 10th year, this event covers both the technological and regulatory aspects of E-Submissions. The mission of the 2006 conference is to help regulatory affairs professionals prepare their staffs, choose a vendor and implement an efficient e-Submissions process. This year's agenda reflects the growing impact of electronic submissions as it shapes your company's infrastructure, technology and ability to remain in compliance.

Conference Highlights:
• Gain an understanding of how to leverage and integrate your current infrastructure and technology in order to cut down on transition costs with case studies from industry experts
• Grasp and identify the investment power of the transition to electronic submissions
• Eliminate fears and trepidation of E-submissions by gaining the confidence in E-submissions which will promote acceptance and usage
• Learn from industry leaders on the challenges and successes of implementing e-submissions

Afternoon Workshop On:
Content Management: Maintaining Content Organization when Transferring between Templates

Conference Day One: Understanding the Value of E-Submission:
The conference kicks off with a session on Streamlining the ESubmissions Process by Starting from the Beginning presented by Edsel David of Daiichi Medical Research. Following that is the keynote address by Pfizer's Global Head of Electronic Submissions, William Qubeck, on Measuring the Return on Investing in E-submissions.

Day One Continues with…
• A case study that provides an in depth view of the challenges and solutions encountered when making the transition to electronic submissions
• Expert regulatory perspective on clarification of current requirements
• A panel of professionals from companies such as Merck & Co., Genentech and TAP Pharmaceuticals exploring what options are available when the industry is faced with a lack of guidance on how to implement e-submissions
• And an overview of harmonization efforts brought to you by the Director of Worldwide Harmonization at Pfizer

Conference Day Two: Preparing Your Systems:
• The conference continues on day two with the tools and techniques that help companies cut down on the cost of implementing Esubmissions and remain in compliance. The day begins with a session on gaining confidence in the E-submissions process and eliminating fear presented by Betsy Fallen, Manager of Worldwide Regulatory Coordination at Merck. Following that is a two part session where Jeffrey Karp, Principal Analyst Research/Regulatory IT for Hospira Worldwide, and Dominique Lagrave, Senior Manager e-Publishing Regulatory Affairs & Quality Assurance at Novo Nordisk, separately discuss the change roles of IT and regulatory professionals, respectively, within a drug company when implementing E-Submissions. Following the discussions the two come together to explore how IT and regulatory affairs works together to achieve quality submissions.

The Day Continues with Our Faulty Presenting Sessions On:
• Working within your infrastructure to keep transition cost low. This session will be presented by Guy Pawson, Manager, Development of Electronic Submissions at Genentech.
• The usage and value of XML, as compared against other types of formatting such as PDF
• Screening and monitoring guidance for vendors

Join us at our 10th annual E-submissions event where we help regulatory affairs professionals prepare their staffs, choose a vendor and implement an efficient e-Submissions process. We continue to bring you cutting edge information paired with expert speakers and ample networking opportunities. We look forward to greeting you on May 17, 2006, in Baltimore.

Sincerely,