IDMP (IDentification of Medicinal Products) is a set of international standards developed by ISO that will become mandatory in Europe in a phased approach, effective from 2018, and will also be adopted by the FDA and globally over the next few years.
In Europe, a legal requirement to implement IDMP comes into effect from July 2016, with the first mandate from third quarter 2018. Pharmaceutical and life science organizations need to start their preparation early, as those that fail to comply with the EU IDMP requirements by forth quarter 2018 can be fined up to 5% of gross European revenue. Capturing the 300–2,000 data entities required per product—70% of which lie in unconnected silos of unstructured text—demands time, resources, and investment. It is estimated that the average organizational cost to do so, across the five required ISO standards, will be around €2.5 million ($3m).
Thanks to recent developments in text mining, manual curation is no longer the only option for extraction of the necessary data attributes. I2E, Linguamatics’ world leading text mining solution, can save your organization time and reduce mistakes on its IDMP-compliance journey.
In this webinar, Linguamatics will discuss the application of I2E for the extraction of key data elements from unstructured text, using Summary of Product Characteristic documents as an example.
Presenters: Dr. Jane Reed, Head of Life Science Strategy; Dr Paul Milligan, Principal Application Specialist.
Date and time: Next date TBD
Duration: 30 minutes, including Q&A
Who should attend?
Managers and directors in regulatory affairs, operations, compliance; plus information and knowledge management professionals responsible for master data management strategies, regulatory information management, IDMP implementation.