The US Food and Drug Administration already requires that submissions for human health prescription drugs be in Structured Product Labeling (SPL) format. It is widely expected that those requirements will soon be expanded to include animal health drugs, biologics and OTC products -- most likely in that order and perhaps as soon as this year. What's more, this development could soon extend beyond the pharma industry, as 2008 could also usher in SPL requirements for medical device registrations.

Meantime, manufacturers selling their products in Europe should be thinking about how to handle Product Information Management (PIM) filings with the EMEA. Though not yet mandatory, leading pharma companies are already looking at how best to prepare their PIM submissions and associated content life cycle management. This audio conference will provide the latest information on requirements for SPL and PIM - where things stand, and where they are headed.

This audio conference covers:

• FDA requirements and guidance regarding SPL submissions
• How best to handle the life cycle management of your SPLs
• What's coming next for SPL?
• The latest information on EMEA and PIM
• How to prepare for PIM submissions, including product information harmonization, translation needs and content life cycle management

About the speakers:

Mark Bayer is Vice President of Business Development for Reed Technology (www.ReedTech.com), providing a wide array of information management services to the pharmaceutical industry and the U.S. government. Mark oversees Reed Tech's Business Development and Pharma Operations team, who are jointly responsible for providing pharma customers with high quality SPL and PIM conversion and related services. Mark holds a B.A. degree in Mathematics from Hobart College in Geneva, NY.

Gary Saner is the Technical Manager of Reed Tech's pharmaceutical SPL and PIM services. He has 24 years of experience in software development, process management and document conversion solutions. He led the successful planning and implementation of Reed Tech's SPL conversion and related services. He has experience managing the conversion process for over 2,500 XML SPL and SPL-PLR labels to date. He has frequent contact with Reed Tech's pharma customers to understand their needs and develop solutions for them. He closely monitors the regulatory environment and is an active member of the HL7 SPL Working Group-Technical and Process Teams, Generics and eLIST sub-teams, and participates in the Veterinary Drug Interest Group (VDIG) and RPS teams. He holds a B.S. degree in Mechanical Engineering from LeTourneau University on Longview, TX with graduate studies in statistics at Villanova University.

Who should attend?

• Regulatory Affairs & Operations
• Documentation Managers
• Labeling
• Submissions Specialists
• Product Information Managers
• IT/IS

This audio conference is rated General Interest.