New Regulation Will Help Drive Patient Safety!!!
Identification of Medicinal Products (IDMP) is a new legislation developed in response to a world-wide demand for internationally harmonized specifications for medicinal products. IDMP is the marketing authorization in Europe for Medicinal Products. IDMP will help drive patient safety. Currently, Pharmaceutical, biopharmaceuticals and biotech companies should be preparing to comply.
Currently, most management at pharmaceutical companies, biopharmaceutical and biotech companies are oblivious to the complexity collecting the necessary data and content. IDMP regulation imposes a very large risk to organizations regarding supporting collecting the data and content to support the IDMP filing. Pharmaceutical, biopharmaceuticals and biotech companies need to look at the IT issues, people skills needed and the data in the organization to support successful IDMP filings.
Data is all over organizations and in multiple languages – different groups (R&D, Compliance, Manufacturing, Procurement) have pieces of the critical data needed for IDMP filings. In fact, some data will be derived from suppliers and CMO’s. One organization has stated they will need to involve over 20 people to collect the key data and content to complete the successful IDMP filing.
Pharmaceutical, biopharmaceuticals and biotech companies need to find and organize the necessary data for IDMP filings. More important is defining a long term strategy to streamline the data and content necessary to support IDMP filings. A Life Science company needs a structured data model for critical metadata and unstructured data.
Unstructured data can be a challenge. Many companies are manually reading unstructured data which is very costly and time consuming. A system is needed that understands how to read and find key information in unstructured data quickly and associated the key data with or within the IDMP data model.
The effected pharmaceutical companies, biopharmaceutical companies and biotech companies need to look at IDMP regulations from the long term. It is not only about data governance but also streamlining a common end to end process to manage the data and content for a product. As a result, companies can drive down the cost of compliance thru integrating an end to end solution into the day to day processes where the IDMP necessary data is created, captured, approved and consumed. Such a process will drive a simplistic IDMP approval and automatic filing process. The time is now to eliminate island system approaches and deploy an end to end common solution on a common platform.