Amplexor ProductExpert™ – helping companies become IDMP compliant

Identification of Medicinal Products (IDMP) standards specify the use of standardized definitions for the identification and description of medicinal products for human use, facilitating the reliable, consistent and robust exchange of product data to enable wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and clear communication across jurisdictions.

Compliance with IDMP requirements presents a huge challenge for life sciences companies, increasing the workload on regulatory resources that are already thinly stretched. However, IDMP also presents a unique opportunity for substantial long-term improvement of regulatory operations.

Amplexor’s IDMP solution, ProductExpert™, is part of its Life Sciences Suite, a holistic Regulatory Information Management (RIM) platform that offers a streamlined approach that enables life sciences companies to achieve long term business benefits beyond IDMP compliance, to drive, manage and control the processes of releasing new products or maintaining existing products on the market.

Benefits of IDMP compliance

The benefits of IDMP reach beyond pure compliance: the target operating model (TOM) defined in Europe will fundamentally change regulatory operations, enabling better quality and shortening time to market for the benefit of the patients, while the standardization of data and processes will significantly contribute to improving operations along the entire value chain.

Amplexor provides IDMP software solutions that enable its customers not just to achieve IDMP compliance but to transform their whole RIM processes, responding to the three most commonly encountered scenarios of IDMP maturity:

1. No RIM system in place: Companies still using spreadsheets to manage the bulk of their regulated product information are provided with a solution that provides a clear path to IDMP compliance aligned with other regulatory needs.
2. Existing RIM platform: Companies that have already deployed a RIM system are enabled to upgrade to next-generation product releases that minimize disruption and maximize the return on existing investments.
3. Creating best-in-breed solution: The life sciences software industry has advocated developing a ‘single source of truth’ for regulated product information. However, open-standards based infrastructure supports connectivity and data exchange with function-specific applications, via APIs. Therefore, companies can still choose best-in-breed suppliers respectively for document management, whether by electronic Common Technical Document (eCTD), for IDMP, or other applications.

Functionality

The Amplexor Life Sciences Suite platform is built on Amplexor’s distinctive strengths in having internal consulting teams with senior industry background, deep knowledge of regulatory guidelines and direct involvement in the design and development process, and a strong partner ecosystem for extensive consulting engagements.

Development of the Life Sciences Suite also draws on Amplexor’s rich experience, including a proven track record on complex data migrations and integrations, industry leadership on XEVMPD, where it developed the first solution on the market with largest share of gateway submitted records, along with engagement in IDMP since the original ISO IDMP standards publication, with a customer circle community of industry experts promoting constructive exchange of IDMP information.

The platform helps pharma, biotech and medtech clients to:

• Manage product data and content in line with the IDMP Target Operating Model (TOM)
• Manage information throughout the products lifecycle
• Plan and track regulatory activities
• Manage interactions with health authorities and other regulatory bodies
• Oversee the authoring, reviewing and approval of submission documents
• Support global label management processes
• Plan, compile, review, publish, and manage submissions

Life Science Suite features

IDMP compliance is a cornerstone of Amplexor Life Sciences Suite featuring:

• Ease of compliance: The ProductExpert™ IDMP solution is seamlessly integrated into an  end-to-end RIM user experience with an intuitive and familiar user interface.
• Data-centric processes: IDMP-compliant data management is driven by a common master and reference data model shared across the complete Life Sciences Suite, while its interconnected data model enables transparent and efficient data-driven change management process, with improved granularity of structured data creating new potential for automated content creation and other business benefits.
• Data connectivity: Flexible connectors allow configurable connectivity to external data sources with integrated support for AI-based IDMP data extraction and Substance, Product, Organisation & Referential (SPOR) master data interoperability to drive external alignment on reference sources. These features allow the Life Sciences Suite to serve as a central regulatory data hub for wider company needs. Direct connection to the submission management capabilities enables automated inclusion of Fast Healthcare Interoperability Resources (FHIR) messages in eCTD sequences.
• Built-in B2B gateway: enables direct submission of FHIR messages and process connectivity, in which the IDMP target operating model is a natural part of the end-to-end RIM platform where IDMP messages are submitted together with eCTD sequence and regulatory activity planning and tracking drives both data and content components of the regulatory submissions.
• Ease of implementation: the platform offers an easy upgrade path from existing RIM and eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) European database for authorized medicines implementations, leveraging and transforming existing data, together with Plug & Play implementation for new customers on premise or in the cloud with full support for data migration.
• Future-proof design: configurable data, content and process model allows for simple adjustment to emerging requirements, evolving processes and emerging common practices while regular product releases bring new or enhanced solution capabilities to keep pace with market needs.

Four step process

Amplexor has drawn on its industry experience, insight and learnings, distilled through its IDMP Customer Circle into emerging IDMP common practices, to create a 4-step process to guide clients on their journey to IDMP compliance and beyond.

The program starts with a consultative IDMP health check, posing key questions to ascertain customer needs, readiness and support required. This then reveals at which step the customer  needs to be onboarded for the IDMP journey:

• Step 1 Awareness: IDMP resources, events and induction training
• Step 2 Preparation: Impact assessments; IDMP data preparation; Project preparation; PoC -> proof of concept
• Step 3 Implementation: IDMP solution implementation; Legacy data transformation; Initial data load
• Step 4 Production: In-process IDMP data enrichment; Data validation; Data submission; Data maintenance; Regular solution updates; Continuous process optimization

Resources

Click on Amplexor Life Sciences Suite for further information and resources.
Click on IDMP Journey for further RIM information
Click on Amplexor Life Sciences Suite – Let us help you to get IDMP ready to view PDF.