DIA EuroMeeting, one of Europe's largest pharmaceutical conferences, will be held in Geneva, Switzerland, from March 28 to 30.
A variety of multilingual documents need to be prepared from the clinical study to the approval of pharmaceutical products. The content structure implemented by using the XML format allows their extensive reuse. Especially in view of the upcoming introduction of the PIM (product information management) standard at the EMA (European Medicines Agency), this is significant for many enterprises. Intended to simplify the central approval procedure, it will play a key role in the approval of pharmaceutical products in the European Union and EEA countries.
Irrespective of the PIM introduction, whose timing has not yet been specified, multilingual contents also occur in DCP/MRP procedures. Though the management of such contents and their comprehensive inclusion (from clinical studies to the core data sheet) pose challenges for enterprises, these activities also enable them to improve the consistency of the texts and to optimize and streamline their internal processes.
Upon introduction of the PIM standard, all previous central approvals must be migrated to the new standard. For many companies, this will mean a considerable amount of extra work and money. In addition, it will be necessary to establish new processes and create data and information structures in line with the specifications of the authorities.
The technology of Across will be instrumental in mastering the challenge of adapting internal processes to the requirements of the PIM standard. If necessary, a consolidated database can be established as the basis for all new product information to be prepared. As a central solution for language resources and translation processes in the enterprise, the Across Language Server comprises a translation memory, a terminology system, and powerful tools for controlling and handling translation projects, facilitating seamless cooperation of authors, translators, and correctors. The open interface architecture of the system enables the perfect integration of the language technology in the respective global labelling or document management system and thus in the general corporate processes. At the same time, full transparency of the translation jobs is guaranteed.