Removing the Risks from Regulatory Content Changes: Keep Control with 'Integral RIM'

20 September 2018

Today, most Life Sciences organizations understand that regulatory information management (RIM) if approached in the right way, could yield much broader benefits. Not only for Regulatory Affairs teams preparing and submitting critical data to the Health Authorities (HAs),  but also across the entire business -  with a more transparent, definitive view of its product and regulatory activities in their entirety and be able to act decisively and strategically in today’s challenging global market. Moreover, this demands an enterprise-wide ability to coordinate changes to product and regulatory information, wherever content is affected.

Getting to this point demands internal IT systems previously architected from the outset to support the confident re-use of master data in different scenarios.

In this webinar, Romuald Braun, Vice President - Strategy for Amplexor Life Sciences, will outline the case for ‘integral RIM.’  This contrasts with attempts by companies to integrate numerous diverse IT systems to try and achieve the same outcome.

‘Integral RIM’ promises true end-to-end product and regulatory insight, with reduced costs and complexity. It offers to drive up information quality and add new value to businesses through process automation - for example, the ability to ‘auto-fill’ documents with pre-approved blocks of content.

Romuald will also explain what’s involved in the ‘structured authoring’ process, and how it could streamline change management – beginning with an instant impact assessment and ensure that all updates happen in all the right places.


Romuald Braun, Vice President- Strategy, Life Sciences, Amplexor
Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.