It has been an open secret for quite some time that RIM can mean anything or very little by the same token - even more an argument to contemplate and reflect on this important topic and to set it into relation to your company´s context. How can this topic be positioned within your organization and what evolution is possible - and what challenges are you likely to encounter when working out your very dedicated RIM scope and journey?

This presentation is an adopted version of two speeches given at the DIA 2016 US Regulatory Submissions, Information, and Documentation Forum and Informa´s Madrid 2016 event on RIM, eCTD Management and Filing Variations.