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.
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. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. Using that scientific background he approaches interdisciplinary and international processes for:
• Lean authoring of regulatory documents (administrative-; quality-; nonclinical-, and clinical documents)
• Managing regulatory information (metadata) across disciplines; products and countries (e.g. eCTD, eAF, ICSR, XEVMPD and IDMP), leading to efficient maintenance of intellectual property, optimal regulatory compliance and necessary signal detection, safeguarding patients and healthy volunteers
• Lean document- and dossier management, resulting in:
o Optimal reuse of documents for regulatory dossiers across products and countries
o Optimal lifecycle management of documents, dossiers and companies
Once these processes are in place, commercial profits will be obtained as a bonus, rather than a goal in itself.
Hans has built up a solid reputation as a consultant for the pharmaceutical industry and is a popular and respected speaker at many regulatory congresses.
He is also heading a sister-company Qdossier (www.qdossier.com). Their services include cleaning of Document Management Systems; mapping and conversion of metadata values; preparation of baseline eCTD submissions; publishing of documents and preparation of regulatory dossiers. Within Qdossier and eCTDconsultancy, Hans leads a dedicated team of specialists who are fully committed to the company slogans “science of submissions” and “first time right”.
Proper regulatory databases, document- and dossier management saves the pharmaceutical industry and agency time and money, leaving them to focus on their core business; namely: Public Health.
Director / Senior Regulatory Affairs Scientist