IDMP Compliance – An opportunity for building Enterprise Data Assets

Biotech, pharmaceutical, and medical device companies need to conform to a plethora of guidelines and regulations, and often, find themselves responding to regulatory needs in more of a reactive vs. proactive manner. The Identification of Medicinal Products (IDMP) is one such regulation that requires all pharmaceutical companies that market their products globally, to ensure that all product data submissions follow a uniform data structure with universal standards and vocabulary. The European Medicines Agency (EMA) is pioneering the implementation and enforcement of IDMP standards using its SPOR (Substance, Product, Organization, and Referential) framework. By early 2023, pharmaceutical companies are expected to begin submitting their product data to the EMA using IDMP-compliant web-based forms.

For an organization to be IDMP compliant, which means adhering to the structures and data attributes as outlined by guidance that the EMA has provided, there are data points required from a variety of different systems and product owners as outlined in the diagram below:

Figure 1: IDMP compliance necessitates the consolidation of data from multiple systems

For a pharmaceutical company to comply with the IDMP standards, it is essential that business and IT stakeholders across R&D, Clinical, Supply Chain, Marketing, and Regulatory work together as a single cross-functional team and find ways to relate cross-functional data. This cross-functional data often does not conform to an enterprise-wide agreed-upon structure or definition and there is a lack of a common technical and business definition of the data. This leads to more efforts on manual curation to ensure that the most accurate and up-to-date data is submitted to regulatory authorities.

Master Data Management (MDM) solutions, by their very function, are well positioned to enable companies to bring together data from across multiple data sources, enforce standardization, and facilitate the creation of an acceptable enterprise-wide “golden record.” Data quality, governance, and management are the bedrock of an MDM solution and are also critical for the success of an IDMP initiative. Data governance puts into place controls and processes to drive better data quality and facilitate a more comprehensive understanding of data across the enterprise. It gives end-to-end visibility to all the data citizens, which includes data stewards, line-of-business users, data governance, and compliance teams. Data stewards can effortlessly locate data, understand its lineage and ownership and obtain comprehensive technical and business context for each data set.

Fresh Gravity’s Molecule to Market Solution

Fresh Gravity’s MDM-driven solution for IDMP compliance, Molecule to Market,

• Brings together data from multiple functions and systems thus allowing organizations to gain a much broader view of their interconnected data
• Lays the groundwork for breaking data silos between distinct functions of the pharma company (R&D, Regulatory, Manufacturing, Supply Chain, etc.)
• Allows the creation of a single version of truth for product data as it moves through the drug development lifecycle. Each stage in the lifecycle adds more details to the description of a medicinal product, and this can be effectively captured in an MDM system. Therefore, this solution is an opportunity to enable pharmaceutical companies to:
• Build a repository of Enterprise-wide Data Assets
• Identify opportunities for and improve Data Quality and Data Governance practices
• Create an Enterprise Architecture view for data across the Drug Development Value Chain and
• Improve Operational Efficiencies

More importantly, the MDM solution generates and traces the journey of a substance from drug discovery to commercialization and regulatory compliance and provides an enterprise-wide view of the data needed across the entire value chain.

Specifically, this solution brings to the table:

• An IDMP-compliant data model with “Medicinal Product” as the anchor entity, thereby ensuring that product data stays at the center of the relationships
• Integration with the EMA reference data service (SPOR RMS) for reference data standardization

Figure 2: Molecule to Market Solution in Action

The working structure of the Molecule to Market solution

Data is ingested through the following data sources:

• Internal Cross-Functional Data
• Enrichment Sources: Additional enrichment sources such as Citeline, DrugDev, and DrugBank can be integrated with the Molecule to Market solution as per the business use case and requirements to add more details to data internal to pharma companies.
• Reference data and/or taxonomies may exist in different systems within the organization. These can be brought into the Molecule to Market solution to standardize the list of values utilized across the enterprise. Fresh Gravity has also developed a utility that uses API calls to populate all the reference data to mirror what is in EMAs SPOR Referential Management Service (RMS).
• Unstructured Data: There is IDMP-related data in unstructured formats across the organization in documents like SmPC, Module 3, eCTD, or the labeling documents. Fresh Gravity has built a Natural Language Processing engine to add an unsupervised learning method where relevant information can be extracted from unstructured data. Extracting data relevant to IDMP from unstructured data sources works as an accelerator that pushes data down into the MDM system.

Once data is brought into the MDM system, typical MDM functions take over, creating an entity/profile and building relationships between different entities. Thereafter, cleansing and, transformation rules are applied to the data, and match rules are applied to find potential matches within the data set. Data Stewards are then tasked with actioning merges to de-duplicate and manage the data from the UI.  Once mastered, de-duplicated, and enriched data is ready, it can be sent to downstream data warehouses from where this data can be consumed by RIM systems for submission to the regulatory authorities.

Conclusion

As IDMP and similar directives include a variety of interactions with various health authorities over a span of time, Fresh Gravity recommends that pharmaceutical organizations opt for an iterative MDM solution. Fresh Gravity’s IDMP approach aims to build a robust MDM foundation that will assist in ongoing data quality maintenance and drive compliance and operational efficiencies in various areas for years to come.

For a demo of Fresh Gravity’s solution, or more information and questions, please write to neha.inamdar@freshgravity.com.

For more detailed information about this solution, please refer to the datasheet here.

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What is IDMP?

If you work in the Life Sciences industry, the term “IDMP” would be familiar to you.  IDMP stands for Identification of Medicinal Products which is a set of standards used to globally standardize data and structures to define and uniquely identify medicinal products. IDMP comprises of a set of five standards developed by ISO, or the International Organization for Standardization.

The five ISO IDMP standards, all of which deal with unique identification and exchange of information for medicinal products, are:

• ISO 11615: Standards relating to Medicinal Product
• ISO 11616: Standards relating to Pharmaceutical Product
• ISO 11238: Standards relating to Substances.
• ISO 11239: Standards relating to pharmaceutical dose forms, units of presentation, routes of administration, and packaging items related to medicinal products.
• ISO 11240: Standards relating to units of measurement.

The 5 ISO standards are illustrated and described in Figure 1:

Why IDMP?

The competitive, dynamic, and highly governed nature of the Life Sciences industry requires a continuous flow and exchange of data between regulatory authorities, pharmaceutical companies, and manufacturers, among other stakeholders. While there has always been a need for efficiently managing submissions and adverse events reporting, there lacked a single mechanism to reliably exchange accurate information between stakeholders. To address this need in the context of pharmacovigilance and improving adverse event reporting, IDMP was developed.

ISO IDMP provides a standard way for defining and storing medicinal product information, which will enable efficient reporting, tracking, faster decision-making, and response during adverse event reporting. At present IDMP focuses on standardization of data with a future goal of improving overall pharmacovigilance[1].

Currently, most of the medicinal product information is spread across fragmented systems within pharmaceutical organizations. Some of the systems are legacy systems and hold data in an unstructured format such as documents, pdfs, excel workbooks, and email messages. Standardizing this data in the IDMP format supports the regulatory submission processes within an organization as it not only maintains uniformity in managing data assets within an organization but also in exchanging data between the regulators (such as the EMA and the FDA) and Life Sciences organizations. The Medicinal Product data previously submitted to regulatory authorities can be re-used when submitting variations to authorized medicinal products. In case of additional requests from regulatory authorities for a submission or a query, the information will be readily accessible. For an Investigational Medicinal Product, as the clinical trial progresses, data generated through different business processes can be submitted periodically and standardization in IDMP format will help maintain transparency.

What has happened so far?

The European Medicines Agency (EMA), a regulatory agency of the European Union (EU) is pioneering the IDMP journey and has organized the implementation using its SPOR services. SPOR is a set of four data management services, namely:

• Substance Management Service (SMS)
• Product Management Service (PMS)
• Organization Management Service (OMS)
• Referential Management Service (RMS)

SPOR covers multiple master data domains of the medicinal products definition. IDMP is being implemented by EMA in phases with different timelines. RMS and OMS services were launched in 2017 and are currently used in submissions that need to be made to the EMA and other regulatory authorities within Europe. As per timelines published by EMA, the next in line is the implementation of the Product Management Service (PMS), expected to go live in Q2 2023. This means that all submissions for medicinal products will need to be made to the PMS service using web-based Digital Application Dataset Integration (DADI) forms (Latest Implementation Guidance IG v2.1 published here). Regulatory organizations, just like the EMA, will be holding the beacon for guidance on IDMP compliance for the industry.

The United States Food and Drug Administration (FDA) has not yet mandated the use of IDMP standards for the submission of data to the FDA. Nevertheless, preparation for EMAs SPOR services will also ensure readiness for FDAs’ future requirements.

Figure 2 is an illustrative depiction of the different approaches undertaken by the US FDA and EMA for defining IDMP ISO standards.

What next?

As IDMP timelines for EMA draw near, Life Sciences organizations are embarking on a digital transformation journey. At a strategy level, an organization can lay down a roadmap for IDMP and align it with its long-term goals to build Enterprise level Data Assets. IDMP compliance is to be viewed as an opportunity to break organizational data silos, improve overall organizational data quality and governance, and enhance operational efficiencies.

Organizations will have to be agile to implement IDMP. Life Sciences organizations and regulators will have to work in collaboration to fully leverage the adaptive, scalable, and nimble technologies available in the market, to achieve 100 percent IDMP compliance.

Did you know about our IDMP solution?

Fresh Gravity has built an MDM-driven solution to address IDMP Compliance needs. Read more about Fresh Gravity’s approach to this here.

For a demo of Fresh Gravity’s solution, or more information and questions, please write to neha.inamdar@freshgravity.com.

For more detailed information about this solution, please refer to the datasheet here.

[1] Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem. [Source:who.int].

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