“RIM provides an integrated view of regulatory information.”
“Affiliates and regions should play a key role in the system.”
“RIM is the foundation of the future IDMP implementation.”
The quotes listed above paraphrase some of the typical feedback we hear from clients about the role of regulatory information management (RIM). RIM is a key supporting structure for successful operation in today’s global regulatory environment. From clinical trial disclosures to regulatory submission tracking, the amount and complexity of data and processes encountered on the path to market makes centralized management essential.
In this landscape of ever-increasing regulations and information complexity, pharmaceutical companies are being pushed to review their existing strategies for managing regulatory information, both within the regulatory department and across the organization.
RIM: The benefits optimizing
Implementing a regulatory information management (RIM) system is vital in the effort to:
- Accelerate the path to market through efficient management of the regulatory submission, commitments, and correspondence information;
- Ensure easy and timely access to the most accurate regulatory data and information;
- Enhance compliance and better track health authority (HA) interactions;
- Improve the exchange of information and collaboration within global regulatory affairs (global vs. regional/local);
- Increase visibility into regulatory activities and improve response to internal consumer requests about regulatory activities and information; and
- Prepare for the IDMP implementation.
These benefits would not be conceivable without defining the RIM system with a clear process, effective resources, data ownership, responsibilities, and access rules.
What type of information is managed by RIM?
The features and capabilities of a particular RIM system will depend on the organization’s needs and expectations. Ultimately, RIM encompasses all information impacting regulatory activities, whether directly or indirectly:
- Product lifecycle management
- Manage substance and product information
- Plan, track, and manage all lifecycle regulatory activities, including submission and registration
- Track and manage health authority interactions and commitments
- Document and submission management
- Compile, publish, and archive files and sequences
- Manage labelling information, including product information documents
- Author the documents, followed by review and quality check
- Regulatory touchpoints
- Manage change control and product release information
- Keep abreast of the latest regulatory intelligence within the whole department
The importance of promoting RIM within the organization
It’s easy to fall into the trap of thinking that RIM concerns only the global regulatory affairs group or that it is limited to regulatory milestones or information. RIM business leads should promote the RIM project/system within regulatory affairs, involving global, regional and local groups, and also with non-regulatory stakeholders that work closely with regulatory (e.g., clinical, pharmacovigilance, supply and global operations, project management, marketing).
Involving the whole organization and identifying the expectations and needs of each group is crucial to support of the RIM project and ensures design of a tailor-made RIM solution responding to company expectations.
Some key aspects to consider include:
- Assessing the types of information/data to be maintained and exchanged via the system
- Implementing data governance, including policies, procedures, and standards
- Defining the most efficient process satisfying the RIM system “contributors” and “consumers”
Any RIM implementation or optimization will not be successful without addressing the aspects of:
- People (resources)
- Process (current vs. future)
- Information (type and format of the data)
- Technology (from multiple and various sources of information to a “single source of truth” and integration between the RIM and other organization systems)
To learn more about achieving an optimized RIM vision and implementation, contact Badr Fathi for access to expert regulatory information management insights and solutions.