Pharmaceutical manufacturers and similar life sciences organizations must keep current, complete records of all submissions and communications associated with drug applications submitted to regulatory agencies — both directly and through their affiliates. Access to complete records of exactly what was submitted wherever a company has applied to conduct business is essential. This includes related communications such as emails, meeting minutes and phone records. These documents are typically scattered across a variety of electronic document management systems (EDMS), laptops, collaboration spaces, email and shared drives — making a comprehensive view challenging.
The tools typically used for the archiving and retrieval of these items simply cannot meet today’s business requirements. For example, companies need to respond quickly to agency queries, requiring immediate access to relevant, up-to-date information. In addition, regulatory compliance dictates that records are protected and access controlled — functionality not normally available with methods such as fileshare sites.
But there’s a better way; namely implementing a purpose-built solution. For example, when working through this process, what if all of your regulatory submissions for medicinal products over time (paper, non-eCTD and eCTD) were centralized and easily searchable, allowing you to view all regulatory documentation and related activity at one time? What if you could look at various submissions for a product, select the one of interest and see all the submissions, queries, telephone calls, meetings and email exchanges along a single timeline?
This article will compare the two main ways of managing submissions to regulatory authorities: using fileshare tools and email, or with a purpose-built solution. Although the first method is perhaps more widely used, it has its distinct limitations. But before we look at methods for managing the records for regulatory submissions, let’s examine the industry’s current state of affairs in this area.
INDUSTRY RECOGNIZES CHALLENGES
The submissions management process is sure to increase in complexity. To get ahead of the curve — and in an effort to improve overall efficiency — companies are beginning to look for alternative approaches to managing regulatory information and communications.
In fact, the recent report “Managing Regulatory Information as a Corporate Asset — Industry, Health Authority and Vendor Trends” makes it clear that life sciences companies are revising their business and technology plans for global submission management. The report, based on an industry study conducted by Gens and Associates Inc., highlights an increasing focus over the next several years on health authority communications. As managing partner Steve Gens explains, “… global expansion is requiring consistency of interactions across regions. … The ability to provide consistent information across global health authorities is critical and difficult to achieve.” Survey responses showed that only 40 percent have an authoritative source for health authority correspondence, indicating a need for additional IT investment in this area.
Thus, the drive toward a much more dynamic approach to information and communications management is an understandable development. “Global submission management is predicted to be the top area of change over the next two years,” according to the report. Figure 1 from the survey shows the areas forecast for greatest change.
To meet today’s complex business requirements, you will need a 360-degree view of all submissions, along with fast access to agency correspondence concerning every product that your company has in the market. Agency representatives will continue to assume that you, the sponsor of a given product, have visibility into everything submitted for that product, along with complete access to previous queries. And because most organizations store regulatory correspondence across multiple repositories, you will need a comprehensive view of all agency interactions in chronological order (Figure 2).
To fulfill these requirements, many companies have defaulted to email and fileshare tools, which are readily available, but more often than not have considerable limitations.
EMAIL AND FILESHARE ISSUES
Today, the most common way to share business information within a company, and among a company and its partners, is via email and fileshare platforms. With this method, information is shared among parties through email transmittals and fileshare sites. Emails are typically used for sharing smaller scale attachments such as Word and Excel files, while fileshare sites are used for larger attachments as these often exceed email system limits.
The main advantages of sharing information using email and fileshare sites are their familiarity, ubiquity and low cost. Virtually everyone is used to working with these basic tools, and most every company has the necessary software installed for email communications. Fileshare sites range from free to very low cost, although costs can climb rapidly as required features are added.