Regulatory Submissions, Information, and Document Management Forum

Several enabling technologies have evolved over the years to support the regulatory operations function but not too many to support Regulatory Strategists. It is time to look at how digital transformation can enable regulatory strategy and regulatory intelligence activities to drive decision making, to streamline analysis, and to improve global coordination. Effective decision making can be supported by the exploitation of information present in RIM systems which requires harnessing quality data and transforming data into intelligence using analytics. Better analytics is possible only through the integration of data across siloed systems and processes not only within Regulatory but also across adjoining functional areas such as Clinical, Safety, Manufacturing, Quality, etc. During this session, we will see presenters making the connection between digital transformation to enable regulatory strategy activities with quality data and analytics followed by a framework on how analytics can be accomplished using existing systems with appropriate examples.