Sep 30 2009
The Center for Business Intelligence (CBI) is pleased to announce the full agenda for their forum on FDA's Structured Product Labeling (SPL R4). The inaugural program will be chaired by Theresa Brunone, Assistant Director, GlaxoSmithKline. The conference will take place in Washington, DC, on December 8-9, 2009.
CBI's speaker faculty always includes the country's leading experts in the bio/pharmaceutical industry and advanced session "SPL Lifecycle Management of Drug Labels" will be a highlight at this timely and relevant event. In addition to targeted 11 sessions and multiple opportunities for networking with industry peers, attendees will have the opportunity to attend a pre-conference workshop -- SPL Primer -- "How to Create, Validate and Submit SPL R4 Documents Successfully."
Top executives from companies such as Amneal Pharmaceuticals, Genzyme, Hoffmann-La Roche, Sanofi-aventis, Watson Pharmaceuticals and Wyeth will assess how to:
- Mitigate financial and regulatory risks through compliance with SPL R4
- Manage overlapping changes to the content of labeling and drug product listing metadata
- Understand where data needs to go and how it works with XML
- Hear about special requirements for veterinary drugs
- Gain tips for working with your vendor in implementing SPL R4
- Learn how to submit through FDA's electronic submission gateway (ESG)
- Obtain the correct D-U-N-S Number for your own establishment and for business
The conference is the industry's best opportunity to identify process and technical solutions to gain operational efficiencies and avoid time-to-market delays. For more information on the conference or to view the entire agenda, please visit http://www.cbinet.com/spl.
SOURCE Center for Business Intelligence