Assessing pharma’s readiness for digital product information management

The European Medicines Agency (EMA) recently published the second version of its European Union (EU) Identification of Medicinal Products (IDMP) Implementation Guide. This means that pharma companies must now assess their readiness for a new world in which data-based regulatory submissions run parallel with and ultimately replace single-use documents.

These latest guidelines should spur software vendors and pharma companies to progress systems that support compliance with simultaneous data-based and packaged-dossier regulatory submissions – all based on the standard vocabularies and descriptors that have been agreed.

Yet this goes far beyond a technology-based transformation. IDMP preparations must encompass changes to processes to ensure they are working with the best possible data, supported by appropriate governance. Organisational changes need to be a part of the picture, to elicit the fuller gains of a data-based product management future.

Assessing readiness for EU IDMP compliance is important right now but also gives pharma firms the chance to prepare for a future in which things will operate very differently. But are pharma companies ready to press ahead, and how should they best approach this challenge?

Four categories of work to assess IDMP maturity

The first step is for pharma companies to make sense of the gaps in their current capabilities and processes. Without doing so, they will struggle to make progress towards their short- or longer-term goals. This means that it is essential to start with an IDMP readiness assessment. This should include clear targets, a realistic roadmap of how to get there and a consideration of organisational, process, information and governance changes, as well as the adoption of smart technology and data management capabilities.

Any company approaching an IDMP maturity assessment should look at four different areas of work.

1. Organisational assessment

As firms begin to realise the power of working with data and a single, central master version of their product truth – managing product-related information will transcend the remit of regulatory affairs. For any pharma firm aiming to fully capitalise on the potential of a new data-focused way of thinking, planning and ensuring quality and safety, it must maintain a consistent, high-quality master data set across the entire organisation, not in different siloes.

An organisational assessment that gauges the company’s readiness for organisational change will help ensure that the right stakeholder groups are given the attention they need throughout the digital transformation that is IDMP implementation. Crucially, this process will assess each employee’s awareness of IDMP and its implications for interactions with the authorities and internal ways of working. It will also provide vital input into the required organisational change management (OCM) strategy and guide a communication plan mapped to the particular needs of each stakeholder group.

Upfront stakeholder analysis – via interview sessions and surveys among identified parties of interest – will also help formulate a near-term change management strategy and a high-level communications plan. This ensures buy-in and alignment across all stages of the project.

2. Process and governance

Many organisations assume that compliance activity begins with the enabling technology. Yet if a world-beating software system is applied to ill-fitting processes, any desired transformation will be hugely impacted. This is why it is vital to review all processes currently affecting how data is generated, captured, checked, combined and maintained, and how this feeds into existing document/dossier creation.

Drawing on industry-standard IDMP process reference models, companies should assess their current business and data management processes and identify the impact IDMP will have on current modes of operation. This knowledge will help inform the necessary process changes – and estimate the effort needed to implement them.

In an IDMP context, data and documents must be consistent in terms of what is provided to the authorities, being submitted simultaneously. So companies must consider whether current processes allow for that and, if not, what will need to change to pave the way for parallel, linked, high-quality structured data- and electronic document-based submissions.

Understanding the current situation will also help with the setup of process design/redesign activities. Depending on the size and scope of the organisation, the data collection, quality control and cleansing requirements, and any new or revised processes needed to ensure ongoing IDMP compliance, could be significant, so companies should not underestimate what will be involved.

3. Technology

The technology assessment must be considered in tandem with process/organisational findings to ensure that any system updates or replacements can support the new target operating model. Furthermore, both individual system and overall architecture provisions must be looked at with an eye on future compliance needs and other data-driven process ambitions.

The goal here for any pharma firm should be to define a fit-for-purpose technology strategy. Topics for consideration/discussion here should include the use of or upgrade to a regulatory information management (RIM) system; use of a product backbone or master data management (MDM) solution; building an in-house solution, or even using EMA’s product management services (PMS) web interface – based on the company’s specific situation and future IT plans.

Where the organisation already has a RIM system in place, it will be important to assess its capabilities in the light of IDMP: its specific configuration, as well as the way data management, has been set up within the system.

4. Assessment of data

The data assessment should aim towards a detailed understanding of the location, ownership, quality and quantity of its IDMP data set, such as it is currently. This will enable the planning of tailored data remediation activities.

Companies are likely to need some help here – to understand more fully the IDMP data model, the ins and outs of the latest EU Implementation Guide, as well as the typical business processes generating and/or handling IDMP data. Performing data pilots with a carefully considered cross-section of current products is advised.

The aim should be to compare internal data sets with both the IDMP ISO standard requirements and the specific definitions set by the EU Implementation Guide. Lastly, in-house data will need to be compared to the data within EU IDMP Referential Management System (RMS) and Organization Management System (OMS).

Once data mapping is complete, companies should have a clear overview of where their IDMP-relevant data resides today, in both a structured and unstructured format; the current quality of that data; which functions own the data or which systems are currently considered the ‘sources of truth’ when putting together dossiers or answering agency queries; which data is currently missing and what this will mean in terms of data remediation; and more.

In addition, drawing on the outcomes of the data mapping undertaking and those from the technology assessment will help draw up a data remediation plan with appropriate activities and timings.

Overall, the results of these assessments will help inform a pragmatic, future-proof IDMP vision and strategy and an optimally aligned IDMP roadmap and implementation plan.

The driving principles of an IDMP initiative

Following the completion of these assessments, an organisation must then develop the main driving principles for its IDMP Initiative. This should start with compliance with EMA’s IDMP implementation and ensure that the IDMP ISO core remains suitable for other regulators’ requirements down the line (such as the US Food and Drug Administration [FDA]’s). Global re-use of the initial European compliance effort is a crucial principle. Another should be to provide a pathway to other business value in the longer term.

These driving principles will set the course for any IDMP implementation, support decision-making and prevent the company from making choices that take it into new silos or technology dead-ends. It is also important to ensure that the IDMP strategy dovetails with or does not conflict with any other pivotal company initiatives.

With the IDMP foundations in place, next steps should include agreeing on the value-driven additional use cases for IDMP, setting the target timeframes for the initial IDMP go-live (or ‘release 1’); and defining the target approach for the xEVMPD-IDMP Product Management Services (PMS) database transition period.

The IDMP end game

The final push should be to set out a clear IDMP roadmap and implementation plan – which does not try to accomplish everything in a first project release. Even if company-wide master data management (MDM) – extending across RIM, pharmacovigilance and safety and ERP – is the ultimate goal, it is more realistic to start with a lean programme that can be added to later.

The incremental increases in IDMP capability should be defined using the outcomes of the IDMP maturity assessment, factoring in three components each time:

1. Compliance-driven components – eg, IDMP EU Iteration 1 compliance, ‘step 1: Central Authorization Procedure (CAP) products’, followed by ‘step 2: non-CAP products’;
2. Value-driven components – eg, batch release optimisation; automatic population of electronic regulator forms; and
3. Supporting infrastructure to enable process and technology implementation data remediation activities, etc.

At this point, the detailed implementation plan for the initial release(s) can be created.

The EU IDMP implementation guidelines have opened up an exciting future for pharma firms, ensuring they can fully benefit from digital product information management. It is a highly complex undertaking that is integral to their future operations. However, starting with assessment, strategy and planning will set them on the right path.