IDMP Preparation and Implementation Across the World

During the recent Global Pharmaceutical Regulatory Affairs Summit (GPRAS) in Berlin, regulatory intelligence leaders articulated why better data quality is the necessary foundation for IDMP success. The Summit was co-presented by Craig Anderson, director of information management at Pfizer, and Vada A. Perkins, executive director of regulatory intelligence at Bayer Pharmaceuticals.

Even within its current limited scope, IDMP creates many challenges when it comes to implementation. While the value of the standards is not disputed, worldwide adoption is slow as the FDA and other regulators scrutinize how to roll out these standards globally.

While that work is ongoing, the conversation now turns to the emerging opportunities of IDMP. There is potential for new system capabilities that use technology to simplify processes and connect data. But focusing just on technology is unlikely to be fruitful. There must also be momentum behind improving processes to ensure better data quality as new technology comes online.

Data is key to process success

Conversations around IDMP frequently center on defining the data elements that identify medicinal products and substances; creating a common language for improved communications throughout the regulatory pipeline, and developing standards that improve IT system communication. Data preparedness, however, is often missing.

Yet success will be determined by the quality of the data underpinning these processes. Without adequate preparation, it becomes challenging to extract data from content, or apply rules to automation.

Perkins notes: “At Bayer, we were thinking about interoperability, compatibility, and being able to reuse structured and standardized data sets that fit into the life cycle model. You have to be strategic in terms of alignment between the US and Europe, taking care to align data models, review what has already been coded, and aiming for a strategy that gives the industry sufficient front-end time to align their internal systems.”

While IDMP and the ISO standards provide helpful ways for teams to represent, expose, and display information, it’s important to consider additional factors that could influence the success of data preparation efforts:

• Staff capabilities. The task of enriching and preparing data may rest with the original creators of documents. These individuals may be experts in process, rather than data experts.
• Global perspective. As processes improve and modernize, they must include models that work globally.
• Data quality. Consider the multi-jurisdictional nature of some information and how it will be used to ensure data quality, particularly if it impacts communications downstream to agencies.
• New organizational focus: A message of accountability and responsibility for information needs to be embedded in the organization at every level.
• Governance. Setting up a meaningful governance structure is critical, especially as information moves through new gateways, within data management systems, and through multiple domains.

The scale of the challenge is evident when working in a typical regulatory IT operating model. This can require moving from registration and tracking to publishing, interacting with dozens of spreadsheets and document management systems, tracking tools, and document repositories.

These complex operating models can become more streamlined and effective when built from a foundation of information preparedness. This results in the type of data quality that makes visualization tools work best. And through IDMP standardization, data visualization is made more effective and helpful throughout the process. For example, it’s possible to use a visualization tool to see a proposed data set next to what was sent previously or view different submissions in parallel.

IDMP creates unique opportunities

The value of information found in IDMP extends well beyond regulatory issues. For instance, IDMP information naturally flows within and around a wide range of systems, including clinical trial management systems (CTMS), data warehousing, manufacturing enterprise resource planning (ERP), substance database, labeling systems, and enterprise document management systems (EDMS).

This interconnectedness is rooted in the technology underpinning each system. For that reason, as health authorities continue to modernize their technology, it’s important that they understand that organizations are also upgrading their technology to maintain the interoperability that IDMP promises.

Updates to RIM solutions can take years, so industry experts are making health authorities aware of best practices that will support the wider objective of modernized systems and standards. Some suggestions that could address the challenges facing current RIM systems include:

• Aligning data models and approaches between the EU and US;
• Creating common languages and common processes for global implementation;
• Communicating advanced notice before implementation.

Perkins adds: “Global submissions and lifecycle management across one product or facility is the primary goal. But long term, we’d like to see international dossiers go through a collaborative and coordinated review process. Ideally, we’d reach a point where we make one submission, through a global RIM system that meets the needs of multiple health authorities.”

FHIR: Interoperability by design

While IDMP sets the standards, it’s important to start thinking about how data works within those standards. The goal is to create a system of interoperability, where information is exchanged across systems, easily and with a minimum amount of transformation and conversation. This is where FHIR (Fast Health Interoperability Resources) comes into play.

Anderson points out that we are already used to interoperability in our everyday lives: “Take Wi-Fi. You can go into any airport in the world, go online, send an email, do your e-banking, shop, whatever you want. Why? Because there’s a set of standards for Wi-Fi that let the internet function. Any device that is compliant with those standards can exchange information with these websites in a seamless way. Unfortunately, we haven’t really had that for health globally, which is where FHIR comes into the picture.”

FHIR is a standard set up by HL7 (Health Level 7) that defines how healthcare information can be exchanged between different computer systems regardless of how it is stored in those systems. Some of the basic elements of FHIR are:

• Common language. Replaces the technical foundation of regulatory affairs, biopharma, and healthcare with the common FHIR language.
• Gateway replacement. Uses a structured API to replace gateways.
• Structured documents. Creates structured documents, which can replace PDFs with XML documents that provide two-way messaging capabilities.
• Advanced communications. Implements services and automated workflows where algorithms and rules can interpret what’s been received and send back communications.

The FHIR bank of Resources streamlines how changes and updates are built and communicated. The Resources are modular components that form the basic data exchange format of FHIR. Currently, there are more than 150 data elements available in FHIR, which encompass data for categories like patients, laboratory results, or insurance claims.

Each uses a common language, which ensures a consistent and predictable method for communication across all systems. For example, when using FHIR resources for product labels, the FHIR dashboard links to all the structured content needed to build the label and can access resources with the most recent content for packaging, labeling, and clinical use.

Long road ahead

There is an energized debate around IDMP standards implementation. This is matched by many organizations taking the initiative to implement tools and processes that build interoperability within this new system.

However, as IDMP and new tools come online, it’s important to maintain a commitment to data preparation and quality. Tools can only function as well as the data that feed them. And as systems grow up around IDMP, they should incorporate global standards and regulations to ensure interoperability now and in the future.

If you were unable to join us at the Veeva R&D and Quality Summit in Zurich, be sure to catch key sessions on demand from the Regulatory zone.