Most pharmaceutical companies lack horizontal process integrations; each business silo manages a subset of information around development and product life cycle. During the life span of a product the same characteristics are exchanged by various disciplines. Different formats are being used, supported by different vocabularies. Consequently information about a product is stored and duplicated across multiple databases and documents, leading to multiple version of the truth.
Today’s world requires information to be transparent and readiliy available. The implementation of ISO Identification of Medicinal Products (IDMP) require companies to collect data from many different sources. Data connectivity and retrievability is challenging due to lack of semantic interoperability between people and systems. Obtaining a single source of truth, supported by a semantic hub, is the solution.
The semantic hub contains all vocabularies in use by the company. It also associates non-controlled terms covering the same concepts and create relationships across vocabularies. The semantic hub can also play a central role when extracting entities from documents. Much data required for IDMP is stored in external approved documents only. By adding new labels to the hub, the entity extraction tool has a broad reference vocabulary to recognize relevant concepts. Later on, when a company moves away form adding structured data on top of unstructured data (documents) the semantic hub can lever the same vocabularies for a structured authoring application.
Director / Senior Regulatory Affairs Scientist
Qdossier B.V.
www.qdossier.com
Hans van Bruggen is Director of and Senior Regulatory Affairs Scientist at eCTDconsultancy (www.ectdconsultancy.com). He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters.
