Time: 8:00am PDT, 11:00am EDT, 4:00pm BST, 5:00pm CEST
Duration: 45 minutes
After delays and uncertainty, the countdown to IDMP is getting closer. The EMA will be the first health agency to mandate compliance with ISO IDMP, with the FDA not far behind. Pharma organizations face a rapidly shortening timeframe to prepare for full transition of regulatory data and systems to comply with this complex mandate.
Publication of the EU Implementation Guidelines v2 in February 2021 started the 2-year implementation window. EU IG V2.1 is due out in June 2021. And, in Q1 2022, the EMA expects pharma companies to be able to submit product data in IDMP format, and by Q1 2023, this will be mandatory.
IDMP (Identification of Medicinal Products) refers to a set of standards designed to standardize the structure and terminology used to describe marketed medicinal products. IDMP’s primary goal is to enhance patient safety by improving the speed, accuracy, consistency, and sharing of adverse events and safety signal reporting globally.
Capturing the hundreds of data entities required per product, 70% of which lie in unconnected silos of unstructured text, demands time, resources, and investment.
However, manual curation is not the only option for extraction of the necessary data attributes. Linguamatics NLP text mining solution can save your organization significant time and reduce mistakes on its IDMP-compliance journey.
In this webinar, we will discuss the application of Linguamatics NLP for the extraction of key data elements from unstructured text, using Summary of Product Characteristic documents as an example.
Who should attend?
Directors and managers in regulatory affairs, operations, compliance; plus, information and knowledge management professionals responsible for master data management strategies, regulatory information management, IDMP implementation.