A modern, holistic, end-to-end regulatory information management (RIM) system can help to greatly improve the efficiency of regulatory data, content and process management, deliver substantial cost savings, and enhance the quality of final output.
Without a modern platform to underpin and help coordinate and track RIM, Regulatory teams are likely to be spending much of their time each day trying to identify the status of a product or its registration/approval status; or track down the latest insights they need to progress a next action or to compile reliable information for regulators.
To be efficient, to contain risk, and to maximise market opportunities, life sciences companies need a clear line of sight across all regulatory activity globally – and a comprehensive understanding of how information is collated, checked, progressed, tracked and managed. That includes the translation of content from and for local geographies; vigilance around differing and evolving local regulatory requirements; and the ability to see and learn from regulatory exchanges where queries and delays recur so that these can be pre-empted in future. The same with any labelling issues.
Where the relevant information or intelligence is difficult to pinpoint, or tasks and content are started from scratch each time, the chance for both process inefficiency and error grows.
Modern, holistic, end-to-end RIM offers to cut through all of these challenges, by providing that central overview, intelligence and control facility, and streamlined end-to-end workflow management. This makes it possible to transform the way regulatory teams – and adjacent functions, where appropriate – work.
Here are 5 RIM capabilities to look for, to maximise the transformation potential.
- Regulatory planning & tracking.
This is the facility to capture a clear plan for regulatory activity and create a central overview of where submissions are up to at any given time.
With a limited, partial or outdated RIM solution, Regulatory professionals usually have to create multiple applications for various markets individually, which is time-consuming and means they can’t readily track or manage any interdependencies between the different submissions. A global programme tool makes it possible to automatically create all applications and see and manage their interdependencies throughout.
As well as creating a global plan that’s more efficient to manage and more readily available to view and follow, companies can look to streamline the way that data is collated and drive up the quality of their data through tighter controls.
- Regulatory content management.
Another practical priority is to understand what content already exists; what will be required for which submissions; and the latest status of related content – and make it easier, faster and more automatic to manage all of this.
Let’s say we’re talking about a submission-ready CMC document, which contains 100 hyperlinks and is used for 50 registrations which will need to be updated frequently. Instead of manually creating and updating all of those hyperlinks across all 50 submissions as part of the publishing process, a modern RIM solution ought to make it possible to create hyperlinks once, in a single document; and the eCTD hyperlinks are automatically replicated where appliable.
On top of the new speed and efficiency, the quality and consistency of the updated content is guaranteed because the definitive update and quality check only needed to happen once.
- Submission management & publishing.
This covers the entire submission preparation process from planning the content, to following its status and publishing it in a format that can be submitted to a health authority.
A holistic, end-to-end RIM solution can transform even the simplest scenario here, for instance looking up the current status of agency approved submission documents for a product which has 50 registrations worldwide.
With limited or outdated RIM capabilities, Regulatory professionals would have to open the details for all 50 registrations in the submission archives and browse the submissions sequences to determine exactly what is currently approved. This can be highly time consuming, especially if affiliates need to be consulted as they have the final versions of the submissions.
A modern platform can transform all of that so that, with a click, the team can see the current registration position directly inside the system (and drill down into the form submission history, as needed), understanding at a glance exactly which documents are approved by a given authority.
- Product registration management.
This is about the management and submission of data about products as they enter and remain on the market across different territories. The aim here is to give Regulatory teams instant access to complete information about a product registration’s validity and its evolving status in individual markets over time and if applicable, to submit it in a structured format to health authorities in the format required.
The benefit of this capability is felt particularly when managing product changes/variations. Instead of manually reviewing all product registrations and creating sequences for all those variations in the submission (which is highly resource intensive), an end-to-end RIM capability will make it possible to perform a global impact assessment. So, when there’s a need update a particular product, the system will quickly and automatically identify where the product is registered, create regulatory activities and submissions all variations that are required and update the respective registration records in bulk – again saving a lot of time and resource, as well as scope for something important being missed.
- Labelling management.
Last but by no means least is the ability to easily track and manage the status of labelling, and any changes to this over time. As well as numerous logistical benefits, there should be scope to monitor exceptions so that these can be addressed pre-emptively and thereby avoided in the future.
The smarter and more automated labelling management is, the greater the resulting quality and safety. Rather than manually review the status of the labels for 50 different registrations, with modern, end-to-end labelling management, it should be possible to access labelling compliance tracking information right across all of the relevant registrations, and view the approved labels, any exceptions from CCDS and other aspects in a single place: the ‘golden source of truth for all labelling’.
Head of Product Management & Consulting
About the author
Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
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