Case
Pharmaceutical industry - Business process improvement project
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Environment
The pharmaceutical world is characterized by a huge set of documents about the description, usage, indications, contraindications and benefits of medicinal products. These documents typically have different formats, structures and content depending on the audience (doctor or patient). They are prepared by the Pharmaceutical Industry and reviewed by the National Competent Authorities, from which the European Medicines Agency (EMEA) in London plays an important organisational role to support the Centralised Procedure.
The structure of medicinal products (i.e. number of pharmaceutical forms, strengths…), the number of languages and the time pressure to market a medicinal product are the logical drivers to use a standardized and better structured approach than the usually used MS-Word format. The PIM project (Product Information Management) intends to rationalise the product information so as to ease the elaboration and review processes of this important information.
Solution
Trasys started the transformation of the product information into a European standard in 2004. The definition of business processes, functional analysis and technical specifications led to the implementation of a Review System for the National Competent Authorities (including the EMEA) and an Authoring Tool for the Pharmaceutical Industry. Since going into production in 2005, the systems have evolved to take into account more complex scenarios, live experience from the effective usage of systems, and downstream usage of structured product information (e.g. for publication). The business and technical knowledge of Trasys consultants has also been used to help a Netherlands-based biotechnology company to review their internal business processes to support the new structured standard instead of MS-Word format. These consulting activities allowed the industry to jump in the new product information approach, for the benefit of the PIM uptake.
Benefits
Even before the system was finalised, benefits have been demonstrated in terms of improved coherence of product information when stored in a structured format like PIM. The use of a Review System also allowed the National Competent Authorities to harmonise their review processes. The Pharmaceutical Industry also acknowledged the provision of the Authoring Tool and highlighted the quality of the support provided by Trasys staff. Additionally, the PIM systems are extended to cover other procedures (primarily the Mutual Recognition and Decentralised Procedures), and to feed internal databases for the storage of product information inside the European Medicine Regulatory Network.