How FontoXML helps pharmaceutical companies comply with future legislation
In Pharma and Life Sciences structured content, or rather structured data, is a hot topic.
Most, if not all companies in this industry are in the process of undertaking a multi-year cross-functional program to enable sustainable compliance with the upcoming IDMP requirements and to improve regulatory master and operational data management practices.
Identification of Medicinal Products (IDMP) is a set of five ISO norms which has been developed in response to a world-wide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of medicinal products, it facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products; pharmacovigilance and risk management). IDMP is the base for the Marketing authorization of medicinal products in Europe. It requires the five ISO Norms being implemented in the Marketing Authorization Application process.
By 2019, Pharma companies will have to submit all information related to the admission of medicine to the market, ranging from clinical trial information to key-data, in XML. This means a shift from narrative text to data, since to date this process is document-driven, using Microsoft Word for authoring and .pdf as the output format.
From narrative text to data
Most medicine dossiers are written in a narrative format. However, the content is rich of ‘master data’ such as manufactured dose form, active ingredient, package-item, product names and synonyms. In addition, dossiers follow a strictly governed chapter-structure, in which a high amount of repetition is present. Furthermore, great parts of a dossier can be considered as following standard templates.
This all results in a move towards component-based authoring with inline variables. It’s not so much the efficiency that drives this move, but the need for consistency i.e. compliance.
From free-form to structured authoring
The process is shifting from free-form authoring, where document-management is the main instrument for content governance, to structured content authoring. And here we see two typical use cases:
- Automated assembly and population of documents and dossiers;
- Narrative, but still component based authoring of (small) parts of the dossier.
In both scenarios, FontoXML helps subject matter experts within pharmaceutical companies to intuitively author those XML components within a dossier. In scenario 1 this also encompasses the creation and maintenance of intelligent XML templates, holding variables linked to master-data, which allow dossiers to respond to their use-context i.e. the location/region for which a submission is prepared.
XML first content creation
Results from several proof of concept projects show that the the willingness of subject matter experts to actively structure and enrich content from the start, is a key driver for successful IDMP compliance. After all, an ‘XML first’ content creation process not only saves a lot of time and costs, it also enforces the content quality needed for IDMP compliance.
For an XML first workflow, we’ve learned, the authoring experience needs to be intuitive and smart at the same time. With smart meaning that the author needs to be supported with tools that make life easy. For example by suggesting preferred terms for words that are automatically recognized while writing or by helping the author to reuse existing content instead of writing more or less the same content all over again.
Smart tooling can turn experts into engaged writers!