Considerable ISO IDMP Standard progress: What is the link and why is it an important consideration in context with eCTD 4.0?
LSCP is specialized in the IDMP standards in context of Enterprise Data Management (EDG) and just recently published the newest development around ISO and health Informatics: Final version for ISO IDMP Implementation Guide (Technical Specifications) for Substances is now available. From a data “Single Source of Truth” perspective, this is something both Industry and Regulators were waiting for!
Content (Data) is normally developed/managed/added/modified/maintained along the product lifecycle with the Substance as the unique originator. Such EDG data foundation will enable a company to consistently use data, for whatever communication target needed.
So, in reality it represents/entails all data elements and their structure (granularity within such element – re-use) that a company needs for their Health Authority (HA) exchange/communication as to the eCTD 4.0 Standard become effective in foreseeable time.
Worth launching a revised thought process?
By Ruedi F. Blattmann, LSCP (Life Sciences Consulting Partners)