Audio Conference

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As Structured Product Labeling (SPL) continues to evolve and become adopted throughout the FDA, organizations must ensure their original approach to SPL compliance is the best strategic fit for the enterprise. Initially, the goal for most organizations was focused solely on implementing systems and/or processes to achieve SPL compliance. Depending on your approach, SPL compliance can either result in additional time and cost to the overall submission process, or provide long-term value across the enterprise.

With additional XML-based standards under development, and the ability for structured content to drive efficiencies throughout an enterprise, it is prudent to review your overall approach to structured content authoring and publishing. This presentation will look at how XML can be used to manage content for SPL submissions to the FDA, Product Information Management (PIM) submissions to EMEA, as well as other uses such as standard response letters for customer contact centers.

This audio conference will cover:

• SPL results to date for human prescription drugs
• Expansion of SPL to devices, vaccines and veterinary products
• Leveraging SPL content for other labeling-related outputs
• How PIM differs from SPL
• Implementing an effective, efficient translation process
• The business case for using XML for standard response letters

About the speakers:

Don Bridges is the Commercial Tech Docs Manager at Data Conversion Laboratory (DCL). In this capacity, he works with customers from life sciences, aerospace, manufacturing, transportation, and other industries to help develop a migration plan that meets business and technical requirements. He is a frequent conference speaker and has written several articles on the business aspects of XML implementation. Prior to joining DCL he worked in the engineering, consulting, and software fields. He has a Bachelor's degree in Engineering from LSU and calls Albuquerque, NM home.

Joe Jenkins is the Life Sciences Market Director for RWD Technologies, responsible for developing and executing an overall strategy for products and solutions serving the life sciences. He has over 17 years of experience in Information Technology and Consulting, with much of that focused on the life sciences. Joe is a frequent conference speaker, and has developed white papers, and contributed to journal articles on life sciences topics. He belongs to several industry groups including the Drug Information Association and the Structured Product Labeling Working Group. He has a Bachelor of Science degree in Computer Science from Pennsylvania State University.

Who should attend?

• Regulatory Affairs
• Directors/Managers of Safety
• IT/IS staff
• Documentation Managers
• Senior Management
• Marketing
  

Purchase recording US$199

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