{"id":46599,"date":"2022-04-18T09:00:31","date_gmt":"2022-04-18T09:00:31","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=46599"},"modified":"2022-04-18T09:00:31","modified_gmt":"2022-04-18T09:00:31","slug":"not-your-average-rims-regulatory-complexity","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/not-your-average-rims-regulatory-complexity\/","title":{"rendered":"How RIMS Help Manage Increasing Complexity in Regulatory Affairs"},"content":{"rendered":"

Managing the submission of medicinal products, medical devices, and biologics to regulatory agencies is growing more complicated all the time. To streamline the processes that go into creating and tracking these submissions, life science organizations are increasingly relying on Regulatory Information Management Systems, or RIMS.\u00a0<\/span>\u00a0<\/span><\/p>\n

What is a RIMS (Regulatory Information Management System)?<\/h2>\n

RIMS<\/a> are software systems that aid in four primary functions: managing product dossiers, preparing and submitting product submissions in regulated formats, managing communications with and obligations to regulatory bodies, and managing the organization\u2019s products by storing relevant details about their registration with various regulatory bodies. These systems are critical because of the complexity of the problems they solve. The regulations placed on medicinal products, medical devices, and biologics are complicated, lengthy, and vary from country to country or even region to region. Consider the cyclical nature of submissions, varying timelines for renewal, and new product candidates completing the Clinical phases at different paces \u2014 there are many moving parts to consider.\u00a0<\/span>\u00a0<\/span><\/p>\n

\"RIMS<\/p>\n

On the surface, all RIMS may seem the same, but how organizations approach compliance can set the leaders apart. A well-managed approach to Regulatory Affairs can shorten a product\u2019s time to market, maximize revenues for the organization, and reduce indirect costs by increasing efficiency, product quality, and patient safety.<\/span>\u00a0<\/span><\/p>\n

Choosing the best RIMS solution for your organization is key to realizing these benefits. Best-in-class solutions have a 360-degree approach to Regulatory Affairs and Operations, are equipped with the tools needed to uncover deep insights from data, and use automation to allow employees to work smarter, resulting in efficiency gains.\u00a0<\/span>\u00a0<\/span><\/p>\n

A Full Approach to the Regulatory Information Submission Lifecycle<\/h2>\n

When it comes to managing submissions, there are two parts of the process: Regulatory Affairs and Regulatory Operations. The Regulatory Affairs team oversees strategic decision-making (such as which countries to seek approval in first) and submissions management (such as planning the various phases of submissions and approvals for a single drug or device candidate). Regulatory Operations, meanwhile, handles the tactical groundwork: the manual collection of data and preparation of submissions, which can be thousands of pages long. It\u2019s important that these two teams work in tandem to keep submissions moving and ensure that products can be marketed and sold.\u00a0<\/span>\u00a0<\/span><\/p>\n

When thinking of the cyclical nature of regulatory submissions, it helps to picture a traffic circle. You can imagine how vehicles may enter and leave the circle from various places. Think of these vehicles as the medicinal product, medical device, or biologic that needs to be approved. Some may enter from the Clinical team, ready to go to their first round of clinical trials, or ready to be submitted for market approval for the very first time. Others may be coming from the market, in need of re-submission to approve product updates or revisions. Still others could be entering from a mid-point between the two, such as when an existing drug is submitted for approval of a new labeled use. Wherever the medicinal product, medical device, or biologic is in the circle at any given time represents where this product is in its lifecycle.\u00a0<\/span>\u00a0<\/span><\/p>\n

Traditionally, RIMS have been described as end-to-end, meaning they help Regulatory teams to oversee the approval of a given product from its inception to its post-market authorization and beyond; but this concept is short-sighted. It neglects to consider that there is no end point when it comes to the product lifecycle. That\u2019s why today\u2019s best RIMS solutions take a 360-degree approach to the submissions and product lifecycle, whether that begins at discovery, renewal, or label modification.<\/span>\u00a0<\/span><\/p>\n

In practice, a 360-degree approach means providing insight to both the Regulatory Affairs and Regulatory Operations teams into one another\u2019s efforts, allowing everyone to stay informed on the status of a given submission and product lifecycle. Most RIMS provide only the information aspect of the regulatory process, pulling completed dossiers and submissions and managing them on their way to the regulatory agency; but 360-degree RIMS allow the strategic function of Regulatory Affairs and the tactical function of Regulatory Operations to stay in lock-step with one another. Leveraging modern cloud technology, these new-age systems eliminate the need for multiple disconnected systems and provide total visibility into every stage of submission preparation, from data collection to dossier writing to the long-term, strategic management of medicinal products, medical devices, and biologics. Think of the RIMS as the GPS directing each individual vehicle: it holds the roadmap needed to keep data, submissions, and workflows moving appropriately and efficiently throughout the cyclical R&D process. These \u201cvehicles\u201d could hold anything from individual data points to content to dossiers.\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

By bringing both Regulatory Affairs and Operations under the same software umbrella, the organization can create a holistic view of the entire Regulatory function to create a more agile, organized, and efficient department. A single system comes with huge benefits, including:\u00a0<\/span>\u00a0<\/span><\/p>\n