Still tracking product registrations in spreadsheets or have labor-intensive business processes for managing health authority inquiries and commitments? You are not alone. Many life sciences firms are still managing regulatory information via spreadsheets, inflexible custom software applications, and manual business processes and would benefit from implementing an integrated regulatory information management (RIM) system. Below are just some of the benefits provided by such a solution.
Greater business productivity freeing up time to focus on other activities
Increased visibility into regulatory activities globally (e.g., what submission was filed in what countries, what commitments did we make and when are they due, health authority correspondence)
Enhanced compliance with product registrations
More consistent health authority interactions
If your company is planning a Regulatory Information Management (RIM) project in the near (or far) future, there are many important considerations project leaders should make to ensure that it is a success.
Key Components of an Effective RIM Capability
Every Regulatory Information Management project will be different, but there are some factors that should always apply. These are just a few of the key components and considerations that life sciences firms should factor into their future visions for Regulatory Information Management:
Health Authority Commitments & Managing Related Follow-up Actions – Understanding the commitments made with each health authority and actively managing project activities to address the commitment before the deadline
Managing Health Authority Correspondence – Streamlining the process of addressing health authority inquiries
Product Registration Planning & Tracking – Plan filings by country or region and easily see what submissions were filed in which countries / regions
Essential Data to Manage throughout the Product Lifecycle
Integrating Manufacturers’ Change Control Processes with e-Submission Updates
Integration with Research & Development, Marketing, and Quality Assurance
Managing Touch Points with Business Partners & Service Providers
Integration with Regulatory Intelligence
Business Process & Data Integration
Organizational Structure & Managing Business Process Change
During your RIM project, you will need to decide whether to purchase an off-the-shelf RIM solution or build your own solution. There are a number of configurable vendor solutions on the market that provide some of the capabilities listed above. Some may fit your needs better than others. It will be critical to define your vision and high-level requirements for RIM before jumping into tool selection. Having a clear vision prior to selecting software will ensure that you select the solution that will work best for your organization in the long-term.
Goal of an Effective RIM Project
Even with all these considerations in mind, creating an effective Regulatory Information Management project plan can still be difficult to imagine. To ensure a successful project, it’s important to start with the right objectives. A crucial goal for establishing a RIM capability is to provide an integrated solution to manage, view status, or participate in essential Regulatory Affairs activities such as registration tracking or commitment management. Regulatory professionals should have one place to go to access information on regulatory activities that provides tailored views into the information by role (e.g., Executive, Regulatory, CMC, etc.).
Planning for Success
To get your RIM project off the ground, you will need to sell the value of developing a RIM capability to obtain funding and support from project sponsors. Next, we recommend putting together a brief project charter to articulate the RIM project goals and objectives and obtain stakeholder buy-in. After taking care of all of these things, you will be on your way to a successful RIM implementation and reaping the benefits.
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Brooke Casselberry, MSRA, RAC, is Paragon's Associate Director of Regulatory Services and subject matter expert. With more than 15 years of experience in regulatory affairs and operations, Brooke has led projects and initiatives involving more than 50 biopharmaceutical companies globally, contributing submissions, intelligence, management expertise and thought leadership.