If you’re in Regulatory Affairs, you know the IDMP-compliance-truck is headed your way. Which questions though are plaguing your team?
- Wondering how to work on the recommendations from an initial IDMP Readiness Assessment?
- Still evaluating if an initial IDMP-readiness assessment will give you concrete visibility on how you will tackle the compliance challenge?
- Or completely weighed under by the ‘Plan a lot; do nothing yet’ worry?
Now is the time to get into some concrete action. It’s time to put the Identification of Medicinal Products (IDMP) assessment conclusions and recommendations in action using technology solutions that can help you validate the assessment, refine data collection process definitions and kickstart the data collection process. If you haven’t embarked on the assessment journey yet, it’s high time to understand how technology innovation in regulatory compliance space can launch and support your assessment phase.
What Does It Mean to Use Technology Solutions to Solve Your Assessment?
To be clear, we aren’t talking about the “big bang,” long-term approach. We are talking about an immediate, get your organization some fast answers based on what you know – to inform a longer-term, more involved strategy. It’s an approach not often considered, which is why organizations get stuck in “analysis paralysis.” We like to think of it as your secret-weapon.
And the timing can’t be more immediate. EMA is going live with referentials and organizations part of IDMP this year. That has immediate impact on you for continuity on xEVMPD compliance. Delay in IDMP deadlines doubles up the challenge. How do you ensure you continue to submit xEVMPD data in compliance with EMA’s new systems – RMS and OMS, while also leveraging that investment to collect data in an IDMP-compliant fashion in readiness for the changeover and not having to implement changed processes and systems multiple times?
To address this challenge, you need to leverage a solution that enables you to:
- Boost productivity of your regulatory data team by using automation to quickly convert your existing xEVMPD compliant data into a central data hub that is xEVMPD + IDMP compliant
- Ensure compliance by leveraging integration with EMA’s RMS and OMS systems in a system that then help you align and re-code your product information to latest controlled vocabulary and organization information from EMA
- Improve data quality by validating your central product data dictionary against relevant current xEVMPD business rules to ensure all required data is in place
- Create a sustainable maintenance process by making electronic gateway-based submissions to the xEVMPD database in readiness for IDMP where web application-based method is no longer recommended due to sheer volumes and maintenance overhead
- Benefit from reduced rework by re-using the central product dictionary for implementing the IDMP assessment recommendations on an IDMP Pilot with showcase products – old historically approved ones, those with multiple-language labeling, combination kit products, approved using varied group procedures in EU
- Kickstart IDMP data collection with coverage against either iteration 1 or the full IDMP scope by testing central product dictionary against IDMP business rules from ISO and eventually from EMA, FDA, HealthCanada and other agencies
- Use quantitative metrics to benchmark current data quality and identify effort required to augment data to be fully IDMP compliant in order to plan for the resources and process optimization budget for upcoming years
Invest in a technology solution that enables you to clearly visualize the end state as recommended by your assessments, or enables you to effective conduct a pilot to actually assess and benchmark your current data quality and effort to reach To-be state.
Talk to ArisGlobal experts to understand more about this ‘Transformation Enablement via Technology Innovation’ approach and get a demonstration of ArisGlobal’s Global Data Standards Compliance Solution agIDMP that is available on its new LifeSphere™ cloud-based technology platform.