IDMP as a Tool for Better Organizational Data
Contributed Commentary by Paul Attridge, Veeva Systems
February 25, 2022 | The clock is ticking on implementing the EMA's IDMP standard. With the release of EU IG v2.1, the industry is in the final stages of preparations for optional submission. While regulatory teams have made progress applying guidance to uniquely identify products and standardize information, more work remains to establish a proper data foundation that supports submissions under the new requirements.
IDMP readiness will be dependent on the state of a company's data. Leaders should be assessing data quality, ownership, and governance and evaluating how to bring together operational teams for better transparency and cross-functional collaboration. Whether you're just getting started or deep in the weeds of implementation for IDMP, here are some practical tips that can help you prepare.
Enabling Data Readiness and Remediation
IDMP will require that companies have seamless data exchange across systems, departments, and external suppliers. This can drive better collaboration and interoperability among pharma, partners, and the EMA. But enabling information sharing is difficult for most since data and system silos make data aggregation burdensome.
To alleviate the issues with fragmented data and systems, organizations should establish consistent interfaces that use the same nomenclature and data definitions. Regulatory leaders can then address and document questions such as who owns the datasets and how the submission process will be managed, which may uncover departmental gaps before data collection starts.
Establish remediation projects to clean data, reconcile sources, and augment missing fields. This should span across the supply chain for necessary data protection and a comprehensive account of all data, sources, and history, information that will be essential for future regulatory compliance.
These efforts are not a point-in-time project. Leaders should build a sustainment plan to ensure all future information is captured in a way that meets IDMP requirements for long-term clean data.
Identifying Data Ownership and Accountability
Every team member must have clear accountability to assure full IDMP compliance. This is especially important because IDMP brings new responsibilities and guidelines that span functional areas. In the same way new hire employee manuals include corporate standards and ethics, there should be documentation on data handling for consistency throughout the organization.
One way to establish a culture of data compliance is to recruit data champions to help explain and onboard employees around governance roles and responsibilities. This can ensure key stakeholders are educated on new data standards, validation rules, and procedures.
Another practical approach for accountability is tying data ownership to each functional area. An awareness campaign can help teams understand how they can work toward achieving clean and exchangeable data together. Sharing data with stakeholders and reinforcing ownership can help teams navigate where information is stored and what should be available on the regulatory side.
Establishing a culture of compliance is critical to driving consistency with IDMP requirements since even one error can lead to lost revenue, timeline setbacks, and government fines. Building teams that lead with this type of transformational and necessary thinking requires ongoing training, commitment to standards, and data ownership.
Maintaining Data Governance
IDMP will bring with it profound change in how the industry approaches governance. To get started, establish a single, trusted interpretation of requirements that can serve as a guide for which data gaps need to be closed.
Since IDMP requires organizations to view internal and external data holistically, including team members across clinical, quality, safety, and other vital areas is essential. This will also help shift focus to the output needed, not on the accrual of data. Transforming narrative content into discrete data elements can deliver increased visibility into regulatory operations and help drive organizational change to address what a company might need as its business evolves.
Once implemented, IDMP will improve data governance through established standards that can speed decision-making and actions around adverse events, enable product info to be shared across regulators, improve assessment and evaluation of medicines, and allow for faster detection of defects or issues. Having clean and consistent data will simplify the exchange of information with the EMA regulatory network.
Modern Regulatory Operations Sit at the Core
Identifying a regulatory information management (RIM) system is a critical part of this journey. The system should scale with business and market changes and incorporate a high volume of change requests easily.
Modern applications have built-in support for regulations and standards to better track, manage, and link registered product data. For example, users can get a complete view into IDMP data sets based on a product's current registered details, as well as capture IDMP elements throughout the regulatory process.
Shifting away from manual information repositories and Excel spreadsheets to a regulatory system on a single cloud platform can simplify IDMP implementation and drive improved quality and compliance. This will deliver better visibility to help organizations become more agile and improve collaboration across teams.
"There is a substantial business case for data sharing throughout the organization," Patrick Middag, IT business partner regulatory EU, Canada, & IDMP at Bristol Myers Squibb, told me during a recent discussion. "We handle most of the IDMP data efficiently within our regulatory system, making the process easier and ensuring compliance."
Preparing for Long-term Compliance
IDMP implementation provides companies with an opportunity to improve business process efficiency and information quality across the entire organization. By changing the data preparation model and eliminating silos, teams can ensure data is part of the authorization and submission process from the onset.
While the transformation won't happen overnight, one thing is for sure—IDMP compliance will require diligence, consistency, and continued focus. We have been watching this space for a while, and especially given the most recent guidance from the EMA, we will continue to monitor the space and update our recommendations accordingly.
Accountability and ownership should be top of mind as organizations rethink their regulatory operations to improve data quality and collaboration. No matter where industry leaders are in their journey, most are drawing the same conclusion: IDMP is everyone's responsibility.
Paul Attridge is a senior technologist and business development professional whose experience spans more than 25 years dedicated to the life sciences industry. Paul leads Veeva's regulatory strategy in Europe. In his career, Paul has held roles in business development, product management, product architecture, software development, and professional services. He can be reached at: email@example.com.