Hanno Ebsen, Senior Manager at Averbis, explores how AI-based data extraction can help you meet IDMP compliance.
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ISO IDMP standards specify the use of standardized definitions for the identification and description of medicinal products to ensure consistency and wide interoperability. For pharmaceutical and biotechnological companies, that means trawling through long, unstructured and complex documents to identify and extract small but relevant content variations between document versions to ensure compliance. This extracted information must be harmonized with predefined controlled vocabulary terms and then electronically submitted to the regulatory authorities.
A traditional, manual approach to this task can take a team of experts days and weeks, always with the risk of human error creeping in. How can we take a radically different approach? By introducing a solution that automates the entire process using machine learning and artificial intelligence (AI).
You can use an AI-powered text mining solution to detect, extract and harmonize relevant entities, such as diseases, indications, drugs, excipients, physical characteristics and many more. Applying this approach to IDMP documents can make the process quick and efficient – 50 SMPC documents in just 15 minutes – with accuracy rates of over 95 per cent. AI can discover 50 plus discrete data elements while distinguishing complex entities like diagnosis and co-morbidity.
As a text-mining company, our job is to reveal data gold, detecting the relevant documents and extracting clinical concepts and relations using our proprietary AI. That’s why we’re integrating our IDMP capability with Amplexor’s Life Sciences Suite to harness the power of AI to automatically mine your documentation and extract the key data in minutes.
Meeting IDMP regulations is a mandatory first step to EMA approval and getting it right can seem onerous, however, we can help you make the process painless. AI will transform this journey and ensure new drugs and devices are approved effortlessly.
Hanno Ebsen holds a Master's degree in Psychology and has more than 18 years of experience in the life science industry. After 15 years in management at a consulting firm, he moved into AI product development for pharma. At Averbis, he is the first point of contact for customers in the life science sector. He loves to add value.