Configure Regulatory Reporting Rules

The regulatory reporting rules are mainly configured to look at Seriousness, Listedness, Causality, and Outcome. Out of these, Listedness and Causality can be captured and controlled (using the event assessment section) down to an individual license basis.

This granularity allows individual license holders to override the normal listedness and causality assessment to control the need for submissions to their local regulatory authority. Each affiliate could either suppress the need for a report by demoting the criteria, or add the requirement for a report by promoting the listedness or causality.

This serves to promote the global reporting automation while maintaining the level of individual local affiliate control that is often needed.

To obtain an assessment of the adverse event, the product must be in the company's suspect product and the event must be encoded.