There has been a common cry for consistency and harmonization in Life Sciences around managing the Intellectual Capital of the business. Efforts started over 6 years ago to develop flexible, open, free and sustainable reference models by the industry, for the benefit of the industry with ownership held by the industry. These have become known as the DIA (Drug Information Association) Reference Models.
- Labeling – a draft is currently published in the EDM model, version 1.3. An update is coming. This update will include refinements based on implementation experience. It will also introduce a new visualization tool that will help users to better comprehend and use the model. This method of graphical representation will be extended to the existing EDM and TMF models as well as all new models. The plan is to release it for public comment, most likely in the second quarter of 2015.
- Quality & Manufacturing – A new model is being built. Previously, coverage in the models for Q&M has been limited to documents in the submission process (within Development). These documents are currently defined in the EDM model (Module 3 of the eCTD, Electronic Common Technical Document.) This new Q&M model will add Manufacturing and Quality documents from the commercial processes that follow marketing authorization. Policies and Procedures will also be included. This new model is a considerable extension that expands the scope of the models to cover more of the Life Sciences business. The current plans are to release this model for public comment late Q1, 2015.
- Medical Devices – Development of a reference model has begun. The pending Regulated Product Submission (RPS) standard, authored by Health Level 7 (HL7), specifies that all regulated products will be covered. To meet that standard, a new Reference Model for Medical Devices is required. A committee has been formed and will work towards a public review sometime, probably late, in 2015.
Even the existing models need maintenance and periodic updates to reflect our Continue reading