The
Early this year, the EMA wrongfooted the market by announcing that, until further notice, the Digital Application Dataset Integration (DADI) user interface, which replaces the electronic Application Form (eAF), will now be the vehicle for structured data submissions for the EMA Product Management Service (PMS).
Go-live is in
Nevertheless, companies can take some clear next steps to realign themselves without compromising either their achievements thus far, or their wider ambitions.
First things first
If you are well into the implementation of IDMP or have a mature data management framework and established data submission processes, it may just be a case of confirming compliance and availability”
The EMA's latest move means that both life sciences companies and their technology vendors need look at their immediate priorities. Full IDMP implementation will still take place eventually and therefore there needs to be a consideration for data initiatives. In fact, the go-live of
Although the
Technology and software vendors will also need to readjust but, it really is just a question of refocusing, so existing investments will not go to waste.
Processes, organisation, technology and information
The new focus on
If you are well into the implementation of IDMP or have a mature data management framework and established data submission processes, it may just be a case of confirming compliance and availability ready for the
But for perhaps the majority, there are some key considerations for discussion.
Processes
The transition to the
Organisation
Organisation focuses primarily on data governance, training and change management, and here there are a number of factors to consider.
- Data governance. Heading towards IDMP, plenty of guidance has already been provided around Substance, Product, Organisation 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, the
US Food and Drug Administration (FDA)'s IDMP implementation but alsoDADI . You need to decide whether to extend your data governance framework to include theDADI fields, and if you want to focus only on the static data elements or also look to standardise the transactional data elements. - Change management. 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 programme momentum. Inform all your stakeholders of the latest revisions to the plan and the impact on deliverables and timescales.
- Training. Timely and relevant training remains critical to ensure that everyone understands not just what has changed in relation to IDMP Iteration 1, but also where
DADI comes into the picture, as well as what the latest developments mean for stakeholders. What are the impacts on them? In practice, what do they need to know?
Technology considerations
Technology vendors and service providers have their own adjustments to make and will want to do everything they can to be ready to support their clients. One immediate challenge is establishing how best to track and manage data across three linked sets of requirements: xEVMPD, PMS and IDMP Iteration 1, each with its own level of granularity. It will take careful thought and close tracking to reduce duplication of effort and frustration.
Without the application programming interface (API) for
Information-related considerations
Given
Take a deep breath
These latest changes give the industry a chance to take stock, allowing organisations to assess their activities and work out how far they still have to go”
The sudden shift in requirements from the EMA might feel overwhelming in the short term, but you can keep moving forward by breaking down the challenge into more tangible and actionable decisions and plans.
For pharma companies that already have an IDMP project well underway, continuing with data remediation activity still makes sense, given the scale of transformation that is ultimately required.
For companies that are not as far along with their IDMP activities, redirecting their projects may be the best course of action, reframing them to incorporate the new
These latest changes give the industry a chance to take stock, allowing organisations to assess their activities and work out how far they still have to go. Companies that adapt to the new requirements while remaining true to their own operational ambitions will stand in good stead for the future.
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