Authoring and Translation in the Life Sciences
Accurate information and communication is of paramount importance in the life sciences industry, where incorrect information about drugs and use of medical devices can lead to fatal accidents - lives can be lost. That, compounded with the enormous amount of information exchanged across international borders, has led life sciences regulatory agencies to promote the use of standardized guidelines for how content is authored, managed and published for approval purposes.
This article was published in ISTC Communicator magazine Spring 2010.
One such standard is the Product Information Management (PIM) system, an XML-based platform for exchange of product information in the context of marketing authorization applications - the first step to being able to market a product in Europe.
Introduced by the European Medicines Agency (EMA) in December of 2005, PIM was designed to increase the efficiency of the management and exchange of product information (Summary of Product Characteristics, package leaflet and labeling) by all parties involved. This electronic exchange of information was developed to improve the quality and consistency of product information, by re-using common content globally and obviating the need for paper documents or materials in Microsoft Word formats - the process used to date.
A similar system - Structured Product Labeling (SPL) - exists for the United States. The purpose, as with PIM, is ‘to facilitate the review, editing, storage, dissemination of, and access to product labeling document content.' One major difference between PIM and SPL is that whereas SPL is designed to facilitate the provision of information, PIM was developed primarily to facilitate the exchange of information.
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