Introduction

Pharmaceutical companies that have medicinal products authorized in the EU and the European Economic Area (EAA) must comply with the ISO Identification of Medicinal Products (IDMP) standard as of 2017 (first iteration deadline). The main objective of IDMP is to reliably identify and trace the use of medicinal products and the materials within medicinal products globally. EMA is the first regulatory authority adopting IDMP, and it is expected that other regulatory agencies (i.e. FDA/USA and PMDA/Japan) will follow in the near future. The regulation applies to all pharmaceutical companies that have marketed or investigational drugs in the EU.

IDMP demands pharmaceutical companies to exchange detailed and IDMP- conformant/standardized data to authorities for each medicinal product. This standardized data relates to approximately 175 (mandatory and optional) data fields referred to as the IDMP data/target model.

The IDMP Business Challenge

The business challenge for pharmaceutical companies is to establish a solution that can integrate, standardize and govern source data to IDMP-compliant standard, and submit/exchange this IDMP information to/with EMA from 2017 and onwards.

When focusing on the core, an ISO IDMP solution must be able to solve the following two main requirements:

• Manage the exchange of IDMP-compliant data between pharmaceutical companies/sponsors and authorities. We refer to this as the Gateway
• Integrate, cleanse and IDMP-standardize data from multiple source systems and verify data according to defined Controlled Vocabularies (CV). We refer to this as Data Hub

For efficient management of the ‘data hub’, SAS provides the SAS^® IDMP Data Hub. This solution is based on extensive data management capabilities and is enriched with IDMP logic to accelerate the necessary IDMP standardization tasks. For a simple high-level visualization of the SAS IDMP Data Hub, please cf. the following diagram.

SAS IDMP Data Hub

When taking a closer look at the data hub, SAS has identified eight core capabilities required for any IDMP data hub:

The SAS IDMP Data Hub is based on the SAS Data Management platform. This is a complete platform for all data management disciplines, including data integration, data quality, management of business terms and reference data, monitoring, role-based collaboration and master data management (MDM).

The SAS IDMP Data Hub adds IDMP-controlled vocabularies, features to add additional vocabularies and standardization rules as they are released from the authorities, extraction of relevant information from text documents, as well as definitions in the built-in Quality Knowledge Base (QKB) for extraction, parsing and standardization of IDMP data types.

With this, pharmaceutical companies can extract and integrate data from all relevant data sources (both structured and unstructured sources), perform data quality checks to ensure that data adheres to the IDMP standards and CVs, and establish an authoritative MDM hub, including feedback mechanisms to update source data in operational systems.

Why SAS for IDMP?

The SAS IDMP Data Hub solution should be seen as the foundational IDMP standardization platform for any IDMP project, where both structured and unstructured source data from relevant systems are integrated, matched to CVs and standardized to IDMP in order to be ready for submission.

With SAS IDMP Data Hub, SAS provides a strong data management platform containing the necessary IDMP standardization capabilities. The key elements that differentiate SAS from the IDMP competition are as follows:

1. A single platform for all IDMP data standardization and data management work
2. IDMP QKB and business rules for more efficient IDMP standardization of source data
3. IDMP target model in the SAS IDMP Data Hub solution
4. Text extraction from unstructured sources (e.g. documents, PDFs etc.) for IDMP
5. Decentralized and intuitive IDMP data remediation to Line of Business users
6. Usability and intuitive user interface enabling customers to build and maintain IDMP data flows in-house or outsource to external partner
7. An IDMP solution and platform that customers can expand and use for MDM, once customers are mature and ready for this (‘grow-as-you-go’). The core foundation of the SAS IDMP Data Hub solution is the SAS Master Data Management solution
8. Deep industry knowledge and experience. Worldwide, several hundred Life Sciences companies in more than 70 countries rely on SAS software solutions (some going back to 1976)
9. Data management is one of SAS’ core competencies, with four decades of experience
   

SAS IDMP Contacts

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