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Completing the picture with regulatory information management
Data, data and more data. Pharmaceutical companies depend on data to bring products to market, but companies struggle to cohesively and coherently manage all that data and all that information. In response, regulatory information management (RIM) has come to the fore, and companies are recognizing its value—at least in terms of how companies communicate with regulatory authorities. But exactly what RIM is and how it fits into the broader scheme of managing products and submissions is perhaps less well understood.
RIM is the method of bringing together all of the pieces of information and data that tell a product's complete story. But it's not used simply to collect information or have a nice picture of data; rather, the purpose is to help companies achieve two things: to stay in compliance with health authorities' requirements and to make well-considered commercial decisions around a product and the portfolio.
Drivers to better oversight
A few years ago, the concept of regulatory tracking appeared on companies' radars, but there wasn't necessarily a clear understanding as to why tracking was a good idea. With changes in the regulatory and commercial landscapes, companies realize they need a better way to track—and, more importantly, manage—critical regulatory information.
First, the need for better oversight of regulatory information must be seen in the context of the regulatory authorities' sharp focus on safety. Health authorities have become far more risk averse, and companies need to demonstrate compliance with the regulations. With that comes a whole raft of data and the need to track that data. Perhaps the most prominent example of legislation designed to provide agencies with more-extensive pharmacovigilance information is the European Medicines Agency's EudraVigilance Medicinal Product Dictionary (EVMPD) mandate. The EVMPD is the European Medicines Agency's central database of what products are registered where. On July 1, 2011, the agency issued a legal notice based on pharmacovigilance legislation requiring that every company submit EVMPD data by July 2, 2012, for its every product authorized in the European Union.
This is a mandate with wide-reaching implications. It requires that marketing authorization holders send to the European Medicines Agency all information on products and substances that would ordinarily 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 the U.S. Structured Product Labeling listings and registrations, though it's less complex for companies to navigate, because the United States is a single regulatory market—meaning, companies don't have alternative versions of products, or translations of product names, or labels they have to produce for dealing with the 27-member European Union.
Other drivers have been the economic climate and companies' realization that they need to do more with less. Very few pharma companies have been untouched by the economic climate as it is today; most of them have eliminated redundancies, and they have not been recruiting, so they have to manage differently both their businesses and the information that stems from what they do. With fewer resources to achieve their objectives, companies are looking to technologies and improved processes instead.
So while regulations require that companies have better control of their regulatory information, smart companies are recognizing the opportunity for using that information to their own advantage—for example, to make decisions about the portfolio and their future direction.
In its early days, RIM was simply seen as a way for companies to track what was happening with their products. Today, however, most business leaders are looking to RIM to give them clearer oversight of the company's products, as well as insight into what to do next. They want not only to know where information is held globally, but also to be able to connect that with data and information coming from other sources. In other words, they don't want simply a static line of data; they want a three-dimensional model that gives them a complete picture of everything that can be done with a particular product.
More than that, business leaders want to be able to see themes and recognize trends in regions, not by looking at just one product but across a portfolio to help them make decisions farther down the line.
By way of example, most large or mid-tier pharma companies have numerous products registered around the world in different ways, under different names and in various formulations. When a new product is about to hit the market, commercial groups will want to know about specific markets so as to determine how best to promote, or even establish, the new product in a particular market. Commercial teams might ask regulatory affairs whether they can market the product in a particular country—from a legal and regulatory standpoint. But without access to information about existing products on those markets, it would be impossible to give the commercial teams the information they need to make a well-considered decision.
From a purely commercial standpoint, RIM is probably the most important way of knowing what, where and when a company can market as well as how future markets are going to look, because the knowledge will be based on information collected about the products a company has in various markets.
Quite simply, regulatory information puts more information at a company's disposal so decision makers are better placed to decide how to move forward.
Challenges to implementation
Companies that have long-established products on the market face challenges to comprehensive RIM because trying to piece together those histories could be overwhelming. Companies have to decide whether it's worth collating information on products that might have been on the market since, say, the 1970s.
It's quite understandable that companies might decide they will start implementing regulatory information management only from the past five years, for example. So the first decision that companies will need to make regards where to start—and that decision will depend on where that company is in its own history and where its products are in their life cycles.
Equally, companies need thorough understanding of how they currently gather and manage information. For example, do they have centralized or decentralized points of control? Where is the information held? And who maintains it? Sometimes companies decide to acquire a RIM system without even considering who will be using it and who will be updating it. Yet those are the two criteria most important to operating a RIM system: (1) knowing who the customers are and what they'll try to use it for and (2) who is going to keep it current.
At the start of a regulatory information management project, companies' biggest challenges are to move into a single, central repository all of the information that exists in databases and spreadsheets and in solutions across the enterprise and to use the same terminology for the same data.
Another difficulty companies face is that because RIM needs to be implemented as an internal project, it lacks the standards available for managing submissions. Moreover, too few comprehensive RIM solutions have been implemented in the industry as yet for best practices to evolve. 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 form a pharmacovigilance perspective; and still others might be most keenly focused on registration tracking.
There's a trend toward greater standardization of product information. For example, Identification of Medicinal Products (IDMP) is an International Organization for Standardization standard that will ultimately replace the EVMPD in 2015. IDMP has at its root the Common Product Model, which is also part of the FDA Structured Product Labeling (SPL) and Individual Case Safety Reports (ICSR) for adverse event reporting, and which will also be integral to the forthcoming electronic Common Technical Document (eCTD) version 4.0, which is modeled on Regulated Product Submissions, the Health Level Seven International (HL7) standard in development to support the U.S. Food and Drug Administration's broad regulatory commitments.
Nevertheless, even though such standards would build greater structure into the overall management of regulatory information, because of the differing needs of companies—small, large, virtual and so forth—the way a RIM solution is maintained will vary from company to company.
Regulatory information management can touch every aspect of a company's business—from product management, which keeps track of what products are on the market and where, licensing status and whether safety update reports are due, to submission management, which is involved with where a company's products are registered, where it is waiting for things to happen, what agency correspondence has been exchanged and requires response and so forth.
Greater opportunities to have information stored in and shared from a central repository—thanks to the development of virtual private networks and the cloud—make RIM more tangible for dispersed organizations, and growing regulatory submission requirements presage the need for improvements in the management of regulatory information. As these factors escalate and as companies become more aware of the potential for better managing their pipelines around the globe for commercial gain, so too will the demand for—and the levels of sophistication of—RIM solutions.
Gillian King is head of global consulting and global professional services at CSC Life Sciences, and has more than a decade of regulatory experience in the life sciences industry. Joel Finkle is senior strategist of regulatory informatics at CSC Life Sciences and a member of the Health Level Seven International Regulated Clinical Research Information Management working group that is developing Regulated Product Submission standards.