The industry is currently in a period of unprecedented transformation, driven by ongoing shifts in the regulatory sphere from document-driven to data-driven information management. This transition is certain to continue well into the next decade and poses a significant challenge to the industry, with profound impact on how we manage regulatory information going forward.
Some of the elements driving this change include:
- The ever-increasing implementation of new standards and regulations across the globe (e.g., ISO IDMP, the Falsified Medicines Directive in the EU, and the FDA Drug Supply Chain Security Act and Pharmaceutical Quality/CMC guidance);
- Significant changes in operating models and systems used by regulators (e.g., the NCAT Global Substance Registration System (G-SRS), the Common European Single Submission Portal (CESSP), and Canada’s Strategy for Patient-Oriented Research (SPOR));
- Significant increases in the data that must be submitted to regulators;
- Historically low business benefit realization of disparate “RIM” implementations;
- The application of new technologies within the regulatory domain (e.g., master data management (MDM) and artificial intelligence (AI)); and
- The ongoing shift in the software market toward end-to-end or integrated cloud-based regulatory platforms.
The meaning and evolution of Regulatory Information Management (RIM)
Regulatory Information Management (RIM) is a term used in different ways in different contexts, with meaning that varies across parties. The term has been in use for approximately a decade now, but the meaning has evolved over time and will most likely continue to do so.
At HighPoint, we define RIM as consisting of the following three pillars:
- Product and Registration Lifecycle Management
- Content and Submission Management
- Regulatory Touch Points
(see figure 1)
As the concept of RIM has evolved, from an initial limited focus on Registration Tracking to an integrated, end-to-end perspective on regulatory information, so has the complexity and also the potential business benefit. While most in the industry now recognize the value in the vision of adopting an integrated, end-to-end perspective on RIM, most organizations are far from realizing that vision in practice.
Figure 1: HighPoint Regulatory Information Management Framework
Disparate islands of information
Many companies are utilizing a variety of systems to manage the various elements of RIM. In fact, it’s not uncommon to find at least 3-5 systems from more than one vendor in use, with typically limited integration between systems.
Documents may be authored, reviewed and approved in an electronic document management system (EDMS) before being manually imported into a publishing system for preparation for submission. Once submitted from the publishing system, the published output may be manually imported into the EDMS or copied to a file share for archival. Regulatory correspondence may be manually uploaded to the EDMS, and once approval is obtained, the registration is documented manually in the registration tracking system. Last but not least, the xEVMPD records are then created based on the approved SmPC in the xEVMPD system (if one exists – in some companies, xEVMPD data is submitted using EVWEB, based on Excel trackers stored in shared folders).
This process typically translates to implementation and maintenance of multiple systems from a variety of vendors. There may be some point-to-point integration, which is costly and cumbersome to maintain, limiting the ability to upgrade individual systems to take advantage of new features. More importantly, though, this means that business processes must be designed around the individual systems, rather than supporting the true end-to-end business process. This negatively impacts employee workload and efficiency. Finally, the majority of the industry does not employ any formal data governance across these hybrid systems to ensure standardization of data, metadata or master data shared across them.
Does any of the above sound familiar? Does your organization have a formal definition of RIM? And do you know your current state in terms of processes, systems and data?
Considering the increasing drive toward greater quantities of data submitted to regulators, it becomes clear that the current state of affairs poses a significant compliance risk in addition to being quite inefficient and a drain on the limited resources of all parties involved.
Getting off the island: Moving toward the vision of an integrated, data-driven end-to-end platform
Acknowledging that the existing, older way of operating RIM is less than ideal, the key questions become:
- What would the ideal future state actually look like?
- Is it achieveable, given the technology available on the market today?
The ideal future state
- Integrated data-driven end-to-end platform
- A shared, standardized regulatory data model across all your regulatory systems
- Ability to author, review and approve your regulatory documents and apply master data and standardized metadata to documents to include in the relevant submission structure
- Drag-and-drop file transfer capability from your ‘EDMS’ to your submission structure in your publishing tool
- Automatically-defined submission structure by submission metadata such as submission type, procedure type and country
- Draft registration record auto-created once a draft submission is created, and automatically updated throughout submission life cycle
- xEVMPD or future IDMP records automatically created based on your registration data, driven by your submission activities and master data
- Draft submission created based on a commitment or the next renewal date
- All of this information made available in a central repository, readily available to all stakeholders and with full traceability of user actions
Can you imagine how much time spent on redundant data entry and reconciliation could be saved? This saved time could now be available to invest in truly value-adding activities instead of redundant data management and administration. And with your data-intensive systems and processes fully integrated, there’s also the saved time and energy from a dramatically reduced risk of non-compliance.
Is it achievable?
Absolutely. The vision outlined above used to be a utopia, but not anymore. Some vendors are already quite far in realizing this vision, and most of the established vendors are actively working to get there.
What does all of this mean to me, today?
Rome was not built in one day, and I am not advocating that all existing systems and processes must be replaced at once. But I am advocating that now is the right time to start, if you have not already. Begin an assessment of your current regulatory information management state in terms of processes, systems and data, then define your desired future state. From there, begin building the roadmap to get there, so you can start executing your successful transition.
For more information about trends in Regulatory Information Management, contact Jens-Olaf Vanggaard.