Venue: Four Seasons Hotel
|Event Date/Time: Jan 26, 2004||End Date/Time: Jan 28, 2004|
As we look at the business of filing electronic Common Technical Documents in 2004, we see a path in the United States that is now fairly well mapped. It still isn’t easy, but it is now more readily understood. In the international arena, it is a different story.
Filing an eCTD on an XML backbone that conforms to ICH standards continues to be a challenge. Foreign languages are tough, particularly from the standpoint of how to maintain the submission in a validated, reproducible system.
With that in mind, we are proud to present eSubmissions, 2004. Over three days, we cover five main areas identified by FDA and ICH as top priorities this year:
FDA’s Guidance for 2004 on the eCTD Expectations for Compliance
The Data Standards Update: A Presentation from CDISC on the ICH Initiative
Lessons Learned in eCTD Filings in the US, EU and Japan through Case Studies
The SEBIX/safe initiative: An Update on PhRMA’s International Data Clearinghouse Model
Document Granularity for eCTD Submissions: Recent Guidance and Options for the Submission Lifecycle
On January 26th, we offer three optional workshops. These workshops provide attendees with in-depth coverage of the issues relevant to our industry and offer an interactive forum. Choose from the following:
B1) Implementing the Common Technical Document in the US
B2) Taking Advantage of XML: A Tutorial and Overview
B3) eSubmissions on a Budget: Using Low Cost, Off-the-Shelf Technologies to Build Successful Electronic Submissions
The eCTD tutorial, always popular is back. It is a morning pre-conference program, led by Octagon Research Solutions. Then we break into two tracks: Arbortext’s down-to-basics workshop for those who want a primer on XML, and for the first time this year, “eSubs on a Budget.” Genentech’s Guy Pawson, renouned for his expertise in creating cost effective solutions for electronic filings, checks out the range of products on the market and helps you explore the possibilities for your own organization.
January 27th kicks off the main conference with a Keynote Address by William Qubeck of Pfizer on the eSubmissions community at the crossroads and what to expect going forward. Throughout the course of the first day, we give the FDA perspective from Michael Fauntleroy, FDACBER. For the overview, we hear a comprehensive report from EFPIA's topic leader. After the lunch break, we hear back-to-back presentations from CDISC's Wayne Kubick and co-presenters Fred Wood of Procter & Gamble and Tom Guinter of Sanofi-Synthelabo on the data standards pilot project with FDA. Rounding out the day, Covances' Carol Stretch has the inside track on just-released guidance on document granularity and the options available to companies for the entire lifecycle of submissions.
January 28th builds on the information we've gained in the first day and updates us on global regulatory requirements with case studies from around the world. This year, instead of projections, we have first hand experiences with eCTD filings in the EU and Japan. The SEBIX/safe initiative, (Infobroker) update completes our regulatory roundup. Then, after lunch, our vendor panel gives us a look at what solutions are available and what will soon be on the market to help automate compliance around the globe. Abbott Labs takes us along on its journey for rolling out an eSubmissions system across a multi-divisional corporation. And we'll take a look at "The Viewer," FDA's system for viewing submissions and making its own, independent queries of the data, through the eyes of the company that designed the FDA Viewer.