21 February 2011 | Article by Thomas Hornbæk Svendsen

Regulations are growing like mushrooms. This is a fact the pharmaceutical industry has to deal with. In order to manage the increasing regulations successfully a new approach as to how the organisation works with information is required. This article claims that by integrating IT systems into critical processes in regulatory affairs a unified, more coherent and beneficial approach is achieved.

A few years ago standards such as SPL, PIM and eCTD were novel and subject to critical discussion. Today, they represent important and consolidated vehicles for standardising the way organisations work with information. And recently, IT systems promising optimisation, integration, improved control and easier reuse of information have become available.

A paradigmatic shift towards true integration
By using IT systems to integrate regulatory tracking information with regulatory documents and product submissions and by setting up global labelling solutions for SPL and PIM submissions, a more coherent and logical process based on content is achieved. NNIT has coined this approach in the term ‘integrated drug regulatory affairs’ (iDRA). Properly implemented, this integration constitutes a paradigmatic shift towards a unified approach to support the business processes critical to regulatory affairs.

From document to content
New electronic submission standards like SPL, PIM and CDISC will eventually require pharmaceutical companies to change their processes and adapt to the new standards. Moreover, it is generally recognized that the use of electronic submission standards allow organisations to streamline processes, making them more efficient and transparent, and eventually reducing time-to-market and thereby turning imposed standards into benefits.

Link information to the business context
Tracking information related to submissions and variations, and requests from health authorities and health care professionals is becoming ever more important. The increase in the number of global products, product mergers and globally available information underlines this development, since both the amount and complexity of information aree steadily increasing. To deal with this challenge, it is necessary to integrate information into the business context, making sure the right information is accessible whenever relevant.

Unleash the benefits of an integrated information platform
With the integration of standards and IT systems the management of product information will change. Discrepancies in the national labelling of products as well as the risk of litigations due to this will be reduced significantly. Integration allows you to terminate the regime of scattered information and disjunctive repositories and unleash the benefits of having one coherent information platform, implemented so that it supports regulatory standards, and provides optimum support for making the right business decisions.

More information
Please call Dieter Schlaps +41 79963 2225 for a conversation about the business benefits by using IT systems to integrate regulatory tracking information with regulatory documents and product submissions.