By Gillian King and Joel Finkle
At a time when the pharmaceutical industry sorely needs to be focusing on product innovation and market expansion, life sciences companies find themselves weighed down by increasing regulatory burdens and the large volumes of data they must generate to comply with each new requirement. While there are no shortcuts to meeting those important regulatory stipulations, there is a way pharma organizations can turn the requirements to their advantage: by using that same data to streamline internal processes and improve planning.
Pharmaceutical companies depend on data to bring products to market, yet many struggle with managing all that data and information cohesively and coherently. Regulatory information management (RIM) can add real value by bringing order to chaos and by giving transparency to complex and diverse business operations. RIM is a method of bringing together all of the pieces of information and data that tell the complete story of a product — from conception to market entry, to ongoing marketing — so that a company can meet the regulatory authorities’ national and international demands.
Once such management is being performed systematically, the process of bringing new products to market is less onerous for everyone involved because it eliminates repetitive, manual information capture and reporting processes and makes it easier to monitor, plan, and influence chains of events. RIM has the potential to even allow individual products to be tracked at a discrete level as they get made and distributed, thereby both improving the responsiveness of product recalls and improving patient safety.
More Standards, More Hoops
As health and safety requirements have increased in recent years — leading to changes in the regulatory and commercial landscapes — companies have come to appreciate the need for a better way to track and manage critical compliance data. In the worst case, failure to meet regulatory requirements could result in products being refused approval or being withdrawn from the market.
In response to product scares and growing patient awareness around issues of drug safety, the health authorities have become a lot more risk averse, introducing higher standards and inserting additional hoops for pharmaceutical companies to jump through to prove those companies’ robust processes and attention to detail. One of the most recent and prominent examples is the European Medicines Agency’s (EMA’s) EudraVigilance Medicinal Product Dictionary (EVMPD) mandate, designed to provide regulatory agencies with more-extensive pharmacovigilance information so that individual batches of product can be traced to their source, associated information dissected, and appropriate action taken without delay.
The EVMPD is the EMA’s central database telling where specific products are registered. From July of 2012, companies will be required to submit detailed EVMPD data for every authorized medicinal product they sell or otherwise distribute in the European Union. This is a mandate with wide-reaching implications. It requires that marketing authorization holders send to the agency all product and substance information that ordinarily would have been stored and gathered by the individual market companies or affiliates and that would therefore not be in one place. Similar information is needed for U.S. Structured Product Labeling listings and registrations, though the U.S. system is less complex for companies to navigate because the United States is a single regulatory market with a single language.
Efficiency and productivity improvements are additional goals of improved RIM, because today’s difficult economic environment takes its toll on the administrative capacities of both the health authorities and the pharmaceutical companies. Having eliminated redundancies and curbed new recruitment, pharma companies must now manage their operations with fewer resources. This has increased their interest in automated processes supported by reliable content management and workflow solutions whose primary goal is to make users more efficient.
Doing More With Less
Forward-thinking organizations have found that they can accomplish several things at the same time if they make the right investments in technology. By looking beyond the basic requirements of regulatory compliance and more closely aligning software with their own internal business strategies — doing more with less, focusing resources on R&D and innovation, and getting products to market faster — organizations are finding they can enhance the returns on their investments, achieving a great deal more for their money.
Once data is being captured systematically and electronically, that data is much easier to find quickly by whoever needs it and at the point of need. This gives companies unprecedented insight into their operations, which they can now exploit in their planning and commercial decision making. Equipped with the right software, companies’ internal teams are given a 360-degree overview of everything that’s happening with a particular product at a given time. At a glance, they can pick out themes and trends in given regions, enabling them to make strategic decisions about their portfolios for the future.
Consider the fact that most large or midtier pharma companies have numerous products registered around the world in different ways, under different names, and with a range of formulations. When a new product is about to be launched, commercial teams want to know about specific markets in order to determine how best to establish or promote the new product therein. Turning to their regulatory affairs colleagues, they may ask whether they can market the new product in a particular country from legal and regulatory standpoints. The response will depend on regulatory affairs having access to information about already existing products in those markets.
From a purely commercial standpoint, RIM is probably the most important means by which a company can visualize its business and develop its strategy — because of the complete profile that such management represents of a company’s existing and planned activities. RIM also provides a means of assessing the knock-on effect of one decision on lots of other activities. For example, a pharma company that changes the manufacturer for an inactive ingredient must be able to plot the updates it now needs to put in place across, say, 14 products in 27 countries. A RIM tool enables those involved to see exactly which submissions would be affected and to plan accordingly. In short, RIM puts more information at a company’s disposal so that decision makers are better prepared to decide how to move forward.
Achieving effective RIM is rarely straightforward, especially when organizations have long-established products on the market that must be mapped retrospectively. Trying to piece together a comprehensive product history is potentially overwhelming. Companies will need to decide whether it’s worth collating information on products that might have been on the market since, say, the 1970s. A more pragmatic approach might be to implement regulatory IM for activities that go back no further than five years, for example.
The first decision a company needs to make, then, is where to start. The decision will depend on where the company is in its own history and where its products are in their life cycles.
A company also will need to acquire a thorough understanding of how it currently gathers and manages information. For example, are there centralized or decentralized points of control? Where is the information held, and who maintains it? Sometimes a company decides to acquire a RIM system without even considering who will be using it and who will be updating it, yet those are the most important criteria to operating such a system: knowing who the users will be, what their needs and goals might be, and who is going to keep the data current.
At the start of a company’s RIM project, the biggest challenge involves moving into a single, central repository all of the information that exists in databases and spreadsheets and solutions across the enterprise and then using the same terminology for the same data. Another challenge is that, because RIM needs to be implemented as an internal project, a life sciences company typically lacks the standards that are available for, say, managing submissions. Moreover, as yet, too few comprehensive RIM solutions have been implemented in the industry for best practices to have evolved. Nor is it possible to produce a one-size-fits-all RIM solution, since the needs of a widely dispersed company will differ significantly from those of a geographically compact company or from those of a virtual company. The reality is that each company has its own way of viewing RIM and therefore its own needs: Some might take a project management approach, others might come at the requirement from a pharmacovigilance perspective, and still others might consider it a means of improving registration tracking.
The Broader The Scope, The Bigger The Impact
Regulatory information management can touch every aspect of a company’s business, from product management (keeping track of which products are available where, the current licensing status, whether safety update reports are due and so on) to submission management (e.g. where the company’s products are registered, any actions that are due and when, and the status of agency correspondence).
The opportunity to store information in a central repository — thanks to the development of virtual private networks and the cloud — leads to further efficiencies by facilitating remote data access and collaboration. This, in turn, makes RIM more tangible for dispersed organizations.
As these broader benefits become better understood and appreciated, companies will find themselves better able to effectively manage their pipelines around the globe for commercial gain, and the demand for, and the sophistication of, RIM solutions will continue to grow exponentially.
In time, the discipline of regulatory information management will only grow in importance, and tight integration between related systems will help increase the impact. By aligning submission authoring and publishing tools (e.g., electronic Common Technical Document systems) with RIM tracking tools, organizations will become able to move information more naturally between systems, turning raw data into decision-supporting knowledge. As ever, the devil is in the details, and the trick is to harness those details and make them pay.
About The Authors
Gillian King is head of global consulting, global professional services, CSC Life Sciences, and has more than a decade of regulatory experience in the life sciences industry.
Joel Finkle is senior strategist, regulatory informatics, CSC Life Sciences, and a member of the Health Level Seven International Regulated Clinical Research Information Management working group dedicated to development of Regulated Product Submission standards.