Amy Williams – Director, Iperion - a Deloitte business
In January 2022, the European Medicines Agency (EMA) communicated their plans for Digital Application Dataset Integration (DADI), which replaces the electronic Application Form (eAF). It will be the vehicle for structured data submissions for the EMA Product Management Service (PMS), until further notice.
With go-live planned for October 2022, companies have until April 2023 to adopt DADI. Fitting DADI into an IDMP strategy—especially for those that have already invested considerable resources and budget in preparing for EU ISO Identification of Medicinal Products (IDMP) implementation – is now upmost in companies IDMP discussions.
There are clear next steps to be taken to realign without compromising their achievements thus far—and remaining true to their broader ambitions.
Regrouping: From Confusion to Clarity
The evolution of the EU IDMP implementation has incrementally become more concrete. With the pandemic we saw the list of data elements for IDMP updated to address topical challenges such as drug supply shortages. In the wake of the pandemic, momentum around IDMP implementation/data submissions was building accordingly: the EU Implementation Guide 2.0; then 2.1; then plans for the imminent release of 2.2.
This latest repositioning requires life sciences companies and their technology vendors to take a step back to reflect on their immediate priorities, not least because DADI-based submissions extend to all EU procedures, not just centralized authorization activities. Full IDMP implementation remains firmly on the horizon and should remain a consideration for data initiatives. Indeed, the go-live of DADI accelerates the submission of structured PMS data. Although the DADI interface only replaces the eAF, its nomination as a means of submitting data in a structured format does offer pharma companies a chance to progress with—and test—their PMS/data readiness.
This is a step forward and progress is tangible. Data-driven processes remain the end goal; data still needs to be captured from documents and aligned throughout the company, and companies still need to prepare for all of this, looking towards future IDMP compliance.
For technology vendors, who have been striving to be ready with IDMP-supporting capabilities, there is a need for readjustment too. Existing investments are not wasted, but a refocus is needed in the interim—for instance on how to manage XEVMPD and IDMP data granularity, and what automation options will be available to facilitate structured data submission.
Practical implications for Consideration
The immediate focus on DADI influences each aspect of your existing (or upcoming!) IDMP programs.
For companies well into the implementation of IDMP, or who have a mature data management framework and established data submission processes, it may simply be a matter of confirming compliance and availability ready for the April 2023 deadline. For others—the majority—there are some key considerations for discussion.
Processes
DADI represents the first step towards realizing the EMA Target Operating model – tying the submission of data to the regulatory activities.
The transition to the DADI webform for the eAF provides companies with an opportunity to evaluate their processes. Who currently populates the eAF for submission? Are they the appropriate resource to populate it within the DADI webform? From where will they retrieve the data to populate it in accordance with PMS requirements? How will they ensure that the data submitted with DADI aligns with the information in their dossiers?
Addressing these questions for DADI from an eAF perspective allows companies to meet the immediate compliance need without disrupting existing/ongoing IDMP preparations. A fuller overhaul to roll-out your to-be data submission and management can come later without the need to rush the critical change management activities required for a successful adoption.
Organization
Organization focus includes Data Governance, Training, and Change Management. These are components whose successful implementation are fundamental to your success. The immediate focus on DADI doesn’t have a huge impact on these workstreams in your IDMP program, but there are a number of different factors to consider.
- Data governance. As you look towards IDMP plenty of guidance has already been provided around Substance, Product, Organization and Referential (SPOR) data specifications, and it makes sense to continue to lay the foundations of your Data Governance in line with these standards. This will serve not only IDMP Iteration 1, FDA’s IDMP implementation (further guidance expected 2022), but also DADI. You need to decide whether to extend your data governance framework to include the DADI fields – and if you want to focus only on the static data elements or also look to standardize the transactional data elements.
- Change management. As ever, keeping everyone informed about the latest changes, the reasons behind them, and the short-, medium- and long-term implications will be important to maintain focus, engagement, morale, and program momentum. Inform all your stakeholders of the latest revisions to the plan and the impact on deliverables and timescales. They’ve seen these “delays” before so focus on the progress and tangible next steps will be critical for your business case and funding.
- Training. Timely and relevant training remains critical to ensure that everyone understands not just what’s changed in relation to IDMP Iteration 1, but also where DADI comes into the picture and what the latest developments mean for the various stakeholders, their data and their processes. What are the impacts for them? In practice, what do they need to know?
Technology considerations
Technology vendors and service providers share much of the pharmaceutical industry’s frustration about the latest changes to EMA’s approach to IDMP implementation. These companies have their own adjustments to make and will want to do everything they can to be ready to support their clients in their new direction. One immediate challenge is establishing how best to track and manage data across three linked sets of requirements: xEVMPD; PMS; and IDMP Iteration 1 and beyond—each with its own level of granularity. Ensuring consistency and compliance across all three with their different data models, will take careful thought and close tracking to minimize end user duplication of effort and frustration.
Without the API for DADI the reality is that some companies will lose automation capabilities for the population of eAF/DADI, in the short-term—which also needs to be kept in mind for resource planning.
Information-related considerations
In the light of the DADI-related requirements for submitting structured data, which span non-centralized procedures as well as centralized authorization activities, companies will need to determine what additional data will now need to be collected. Where does this reside? How much is already tracked within a RIM system or structured format? A further consideration is when and how to factor in additional data fields that will be needed in next phases.
Maintaining Perspective – and Momentum
This shift in requirements needs an immediate review and decision in the short term. The most pragmatic approach is to break down the challenge into more tangible and actionable decisions and plans, making it possible to keep moving forward.
Where pharma companies already have an IDMP project well underway—and have made good progress preparing for Iteration 1 for centralized procedures—it’s important not to suddenly press stop. Continuing with data remediation activities still makes sense given the scale of transformation that is ultimately required.
Those companies that aren’t as far along with their IDMP activities may be able to redirect their projects; reframing them to incorporate the new DADI-related requirements at this stage and pushing out Iteration 1 compliance to a later phase.
Ultimately the latest changes provide the industry with a chance to take stock of what they are doing, and why, and how far they still have to go. The changes required to implement structured data submissions for DADI compliance are not insurmountable.
We believe that the end objective should be the optimization of the regulatory process and reducing the administrative burden for all stakeholders.
Those companies that are able to adapt to the new requirements while remaining true to their own operational ambitions will set themselves up well for a data-driven regulatory management future.
Amy Williams, a Director at Iperion - a Deloitte business, has 15 years of experience in Life Sciences Regulatory Affairs, particularly in optimizing regulatory information management systems (RIMs). Iperion, now part of Deloitte, is a globally[1]operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardization and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.
https://iperion.com/
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