IDMP’s challenges for the pharmaceutical industry (cancelled)
The International Organization for Standardization (ISO) Drug Identification Standards (MDIS) specify the use of standardized definitions for the identification and description of medicinal products for human use. The aim of these standards is to facilitate the reliable exchange of information on medicines in a robust and consistent manner, providing a common product “language” for stakeholders to use in their interactions.
The five standards include information on the regulated medicinal product; information on the regulated pharmaceutical product; units of measurement; dosage forms, units of presentation, routes of administration and packaging; and structured substance information. Taken together, these standards allow regulated pharmaceuticals to be uniquely defined, characterized and identified throughout their entire life cycle, from development to authorization and marketing.
IDMP will be a game-changer in the use of process and technology integration to improve patient safety. IDMP will offer companies the opportunity to make product data work more efficiently from a business standpoint, through improvements in data quality and use
This will be a revolution in the pharmaceutical industry much like what happened in banking with the advent of the Basel regulations.
Is our pharmaceutical industry at the optimum level to meet this challenge in terms of data management and quality, and will it be possible to map all the processes as required by the regulator?
This roundtable was cancelled info here