Streamlining the regulatory submission process is essential to getting products to market faster today. And yet, for most Life Sciences organizations, this process is time consuming, inefficient and complex – even more so when partnering with Regulatory Affiliates worldwide. While sponsors are ultimately responsible for the safety of the products available in global markets, they struggle to gain visibility into regulatory activities. On the flipside, Affiliates struggle to get access to critical submission documentation in a timely manner and to create an efficient process while using a whole host of local tools (spreadsheets, network drives, email, paper, etc.) to manage their work. The result is a disjointed process that lacks efficiency, traceability and streamlined communication.
Next week, the Drug Information Association (DIA) is hosting their Regulatory Submissions, Information and Document Management Forum in Bethesda, MD. On Tuesday, EMC’s own Mary Gallagher, well-known in the industry, will be speaking on “Managing Global Submissions – From Identifying Core Content to what is Actually Submitted.” I had a chance to speak with Mary about her presentation and why she thinks it’s an important topic to highlight.
Question: Mary, when you say “Core Content” or “Global Regulatory Index” what do you mean?
Answer: I am working with several clients on the concept of a Global Regulatory Index (GRI). (Some clients also refer to this as a Core Dossier or Corporate Package.) The objective is to create a package of all sponsor approved submission content for a given product at any point in time. This content would be created and approved by the Sponsor and could be used anywhere in the world for submissions. Local Operating Companies (LOCs) / Regulatory Affiliates could then create local health authority submissions based on the approved GRI.
Question: What is driving the need for something like this in the industry?
Answer: The underlying driver is the desire to reduce risk and improve efficiency. Sponsors are ultimately responsible for all heath authority submissions and yet there is a real lack of visibility of what Affiliates are submitting as well as concerns about accuracy. In Gens & Associates’ 2015 RIM and affiliate benchmark study, it found that 40% of affiliate time is spent coordinating and managing regulatory information, with approximately 25% of that time spent on non-value-added activities, such as data re-entry.
In our interactions with clients, there seems to be a lack of confidence in the quality of product registration information maintained in global systems. Companies are looking for ways to ensure accurate information and a single source of the truth yet ensuring that Affiliates have the information and easy access they need to unify both the process and ensure timely, bi-directional communication.
Question: What would be required to utilize a GRI?
Answer: First, a process would need to be defined that takes the needs of both the Sponsor and the Affiliates into account. The goal should be to define a process that works for both parties and reduces non-value add activities and rework. Obviously, it also needs to be flexible and adaptable to manage global regulatory requirements while helping to ensure compliance. Another thing that is necessary is that the business process needs to be intuitive requiring minimal training and limited oversight of affiliates who have limited time and resources.
Question: How would the GRI be structured?
Answer: Ideally, we would recommend creating it by using a Virtual Document (VDoc) in Documentum. For those unfamiliar with the term, a virtual document is basically a document composed of other documents. It’s a way to organize (and “granularize”) complex documents or submissions, which are authored by multiple authors, sometimes in different functional areas. Check out this short video. Virtual Documents also boost efficiency by enabling certain functions to be performed on a large number of documents in a single action (such as sending a task to a user to have them work on a virtual document instead of having to send and track multiple documents individually.)
Question: Who would “own” the GRI and how would it be kept current?
Answer: There are numerous people and systems involved in creating a regulatory submission. From a process perspective, the Product Portfolio Management team would be involved as they determine where new products will be marketed and create the overall product marketing strategy. From an ownership perspective, the Submission (GRI) Manager would define the content and timeline of the GRI releases. This person would also communicate with the content authors, LOCs/Affiliates and ensure that everyone has the tools they need to meet the required timelines. When there is a change to the GRI, Affiliates / LOCs can be notified via email with a link to the GRI (and a read receipt for compliance tracking purposes) or via a task in their Regulatory Submission planning tool.
Question: When talking about access, what kinds of security concerns need to be addressed?
Answer: Ideally, the GRI would be posted in a secure location such as a Sponsor’s content management system. LOCs / Affiliates would have access directly to the GRI. However, due to the availability of very granular security, access permissions can be set so that Affiliates only have access to approved content and only content relevant for the products sold in their market. In addition, Affiliates would only have permission to read and copy the content – they could not edit and revision the content. This provides the Affiliate with easy access to relevant content but ensures Sponsor control over the content itself.
Question: This all sounds like a much more efficient way to work. What additional advice would you give Sponsors and Affiliates?
Answer: There are multiple questions that need to be answered when defining a GRI and the associated processes. In addition there are numerous tools and systems involved in the Regulatory Submission process and they can help facilitate information sharing and increase efficiency. I encourage any company struggling with this process to talk with their content management vendor and also their registration management and publishing vendors. By working together, companies can develop a process that enables end-to-end visibility, ensures a comprehensive single source of truth for both Sponsors and Affiliates, facilitates communication and (hopefully) speeds time to market.
- How does your organization handle this process today?
- Do you experience any of the challenges discussed?
Let us know about your experience and goals! And, if you or a colleague will be attending DIA’s Regulatory Submissions, Information and Document Management Forum next week, be sure to catch Mary’s full presentation on Tuesday, February 9th from 10:30 – 12:00pm in the ERS Track!