30.03.2005 20:04:00

Innodata Isogen Webinar Series Addresses Structured Product Labeling P

Innodata Isogen Webinar Series Addresses Structured Product Labeling Pitfalls / Opportunities; Drug Makers Scrambling to Comply with FDA Deadline


    Business Editors/Health Editors

    NEW YORK--(BUSINESS WIRE)--March 30, 2005--The long-term benefits of Structured Product Labeling (SPL) have created many short-term headaches for drug makers as they scramble to comply with the Food and Drug Administration (FDA) deadline of late 2005 for converting drug-related labeling to XML. However, by embracing the SPL mandate as an opportunity to streamline the process for producing label information, some pharmaceutical companies are turning this regulatory requirement into a business advantage.

    Innodata Isogen, a leading provider of content supply chain solutions for the information industry, will be conducting two SPL Webinars that will address ways to optimize SPL requirements and avoid common pitfalls on Wednesday, April 6th and April 13th; 12:00 EDT, 9:00AM PDT, 17:00 GMT. For more information or to register, go to http://www.innodata-isogen.com/resources/spl?dref=bw

    Shepherding huge volumes of content through multiple internal and external hurdles for drugs on the path from the research lab to the marketplace is an ongoing challenge for pharmaceuticals. The question for drug makers is whether they will treat the conversion of product-labeling documents to an open-source digital format as an opportunity or a curse.
    Extensible markup language (XML), the open-source code the FDA mandated for SPL, has a long track record of success in other industries for supporting single-source publishing systems. XML has the potential to not only speed up FDA review of initial labeling and post-approval labeling changes, but also to help the agency communicate accurate information easily and rapidly to physicians, pharmacists, and patients.
    "Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, more and more drug companies are considering a full XML-based overhaul of their system. However, the road to SPL compliance is also filled with potholes that could derail their efforts," said Dan Dube, director of business analysis for Innodata Isogen. "Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential, will seize a competitive advantage and drive significant improvements throughout their organization."
    For a free in-depth report on Structured Product Labeling, go to http://www.innodata-isogen.com/resources/spl?dref=bw

    About Innodata Isogen

    Innodata Isogen (www.innodata-isogen.com) provides business and technology services that help organizations create, manage and distribute information more effectively and economically. We are headquartered in Hackensack, New Jersey, just outside of New York City. We have two additional solution centers in North America, seven content production facilities in North America and Asia (the Philippines, India and Sri Lanka) and a technology and tools development center in India.

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CONTACT: Kitchen Public Relations Anne Steinberg, 212-687-8999 anne@kitchenpr.com or Greg Jones, 212-687-8999 gjones@kitchenpr.com

KEYWORD: NEW YORK NEW JERSEY INDUSTRY KEYWORD: LEGAL/LAW MEDICAL DEVICES PHARMACEUTICAL MEDICAL BIOTECHNOLOGY CONFERENCE CALLS SOURCE: Innodata Isogen

Copyright Business Wire 2005

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