RIM efficiency and IDMP standards share similar requirements: Quality data, global alignment, and inter-departmental collaboration.
A surge of change is underway in regulatory information management (RIM) as life sciences companies re-evaluate their global operating capabilities. A recent report by Gens and Associates shows that many organizations are embarking on significant transformation initiatives.
Mounting pressure to operate more efficiently worldwide is driving companies to harmonize processes, improve data quality and adopt shared global systems. For many, the spark of this movement is the Identification of Medicinal Products (IDMP) standard that requires regulatory teams to collate data from multiple sources and functions.
As companies work to meet IDMP requirements, many are proposing changes that have far-reaching impact. One such company, UCB, got an early start on a transformation initiative supporting IDMP readiness. Gordon Topping, UCB’s senior director of submission portfolio and regulatory knowledge management, is a member of EMA’s IDMP/SPOR task force and advocated for a comprehensive strategy around IDMP preparations.
By modernizing their RIM capabilities, UCB has improved the efficiency and agility of the business and translated data quality into patient value.
The Pace for Change Accelerates
Industry analyst Steve Gens has been following RIM trends for more than a decade and has captured significant changes in the latest Gens and Associates report, Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures and Priorities. A dramatic 86% are embarking on transformational change in one or more of the 17 regulatory capabilities tracked.
“We are seeing an unprecedented level of change in regulatory,” Gens said. According to the survey, 41% of large and mid-sized companies plan to change their submissions content management systems within the next two years; 65% are changing their submission planning systems, and 73% are changing systems for managing health authority interactions.
Regulatory transformation initiatives are also bigger and broader than they used to be.
“Historically, we’ve seen regulatory capabilities upgraded incrementally with individual change initiatives,” added Gens. “Today, regulatory change is treated as an end-to-end program with colleagues from clinical, quality, and manufacturing participating.”
Companies are reinforcing their new RIM strategy with organizational changes — for example, 45% of companies report implementing end-to-end process ownership and governance roles.
Generally, companies are pursuing four key goals:
1. Global Harmonization
There has been and continues to be a shift toward standardized systems with a common RIM model. “Companies are moving from a disparate RIM model where systems vary by geography or product, to a common RIM model in which they use shared global systems,” Gens said. “Companies are taking a more holistic approach, managing regulatory processes globally, and their efforts are paying off.” The new research shows that companies with a common RIM model are 3.5 times more likely to realize business benefits compared to those with disparate RIM environments. Companies with a common RIM model are also 18% more efficient than their competitors with disparate RIM systems and have 2.5 times more confidence in the quality of their data.
2. Data Quality
The quality and reliability of data is also a top priority in RIM transformation. Today, companies need to check and re-check information anytime they use it, which is a heavy burden. Regulatory spends a lot of time verifying information before it goes to health authorities or senior management. Accordingly, 88% of respondents are currently changing or planning a change to their data management capabilities within the next two years.
A third force driving transformation is the desire for greater efficiency and productivity. Gens noted, “The average self-reported level of efficiency across 17 areas is about 39%, which is very poor.” Another measure of efficiency is the time needed to provide accurate reporting for basic regulatory questions—such as the status of a label change in an affiliate office. Half of the participating companies took days or weeks to provide accurate answers. Given the historic focus on compliance, it is not surprising that few companies measure RIM efficiency, but that is now changing.
A fourth priority is improving processes connecting regulatory with other functional areas. A manufacturing change, supply release, or label change are three collaborative processes hampered by poor data quality and accessibility. Inefficiencies in cross-functional collaboration are particularly concerning since they often introduce compliance gaps. IDMP requirements have forced these separate departments to get aligned around data, and process improvement is a natural component of those conversations.
In addition to these four drivers, are the initial findings from internal IDMP-readiness projects that are adding a sense of urgency to the desire for change. Gens explains, “Many companies completed their IDMP gap analysis and were alarmed by the size and complexity of the necessary IDMP compliance project. They are subsequently focused on how to keep this mission-critical data clean and updated over the long term.”
Regulatory Transformation at UCB
According to UCB’s Topping, what started as an IDMP readiness program quickly became much more.
“Initially, the first priority was to comply with IDMP, whatever that would come to mean as the guidance was finalized,” Topping said. “The second priority was addressing batch release — making sure what was released to any given market matched the regulatory file. We wanted to work with a specific use case that provided business value and involved a meaningful sample of IDMP data. The third priority was product master data management.” However, he said, company priorities have evolved substantially, relegating IDMP compliance to simply a byproduct of doing other things correctly.
“We did a lot of internal communication around IDMP, particularly viewing it through the lens of patient value, and were transparent about wanting to address important business and compliance objectives as part of our initiative,” said Topping.
UCB formed a cross-functional team, and outlined six core objectives. Within each, UCB focused narrowly on what was business-critical and would provide real patient value, recognizing that with a strong foundation in place, it would be able to scale up and address additional IDMP data points as needed.
UCB’s Six Core Objectives for RIM Transformation:
- Data collection monitoring: The company sought to create a routine monitoring framework that would ensure the completeness, accuracy, and timeliness of updates to product license information.
- Information availability: While regulatory traditionally works behind closed doors, UCB decided to make regulatory information more widely available internally. They started with the supply release process to fully ensure that product in market matches the regulatory file. “We were managing product releases with emails and spreadsheets,” said Topping. “We now provide weekly reports with the status of all CMC or regulatory variations for each product in every country. Going forward, we’d like a more interactive technology with real-time dashboards.”
- Unified regulatory processes. Historically, regulatory professionals have thought in terms of individual software applications instead of end-to-end processes. Topping explained, “People tend to think about document management as its own process, and registration tracking as its own process. The same holds true for each tool. We created an interactive process map that is system agnostic. You will eventually be able to go from submission planning to archiving without logging into multiple systems. We are not there yet, but we are working toward this and it creates a very different, much more effective way of working.”
- Document and data collection remediation. Topping shared, “Locating the source materials for IDMP data collection is a major frustration. All too often the needed documents are located at an affiliate or a partner company. We now have an ongoing program collecting all of the source documents, extracting the information, and converting it into data.”
- Master data management. UCB started by mastering a small handful of data fields. It identified fields that were frequently duplicated between systems and would deliver significant business value if standardized and shared, including: product name, strength, formulation, and country. “MDM is the most transformative piece for us. Simply being able to link manufacturing stock keeping units with registered package details has been huge,” Topping said. “Connecting into systems like SAP, TrackWise, and Veeva Vault RIM will result in enormous value over time.”
- Operating model optimization. Once data flows and systems are running smoothly, UCB could step back and evaluate the overall operating model to optimally maintain these data. “Many of our regulatory activities like publishing are already largely outsourced, but when transferring or sharing documents around the world, you need reliable performance. That was a good reason to move document management to the cloud and get supporting processes in place.”
Innovation Enabling Transformation
Improving RIM efficiency and meeting IDMP standards share many of the same requirements: Quality data, global alignment, and inter-departmental collaboration. The opportunity to innovate and achieve these goals is greater today than it has been in the past decade.
“The RIM technology space has been relatively stagnant for a long time and is now changing,” Gens said. “There are several new providers bringing much needed usability and innovation, replacing older systems that are hard to use globally or are inefficient.”
Companies may have once balked at the effort involved in standardizing systems, processes, and data globally. However, it is increasingly clear that the gains in operating efficiency and regulatory effectiveness will generate a positive return and have motivated many to embark on their own transformation initiatives.
(John Lawrie, VP of product strategy for the Veeva Vault RIM suite of applications, is responsible for product direction supporting registrations management, health authority interactions, and submissions content management, archiving and viewing.)