The EMA recently announced that they will be delaying the roll-out of the new ISO IDMP standard within Europe until after the completion of the formal Brexit processes. This means that no EU Implementation Guidelines (EU IGs) will be published in 2018, and there will be no need to start submitting product data in the new format in 2019.
It may have caused a disturbance in the industry, but whether you were skeptical about the original implementation deadlines or not, one thing remains - IDMP will still happen, with or without Brexit!
So how should you react? Is this a time to relax and enjoy some spare cycles in your day? Or, is this your opportunity to be proactive and push forward with your plans knowing that IDMP is not only about regulatory standards, but also a significant opportunity for your business to improve its own internal data handling processes?
The choice is yours, but with so much to be gained these are our top five reasons for continuing at pace with your IDMP roll-out:
1. Set your data free and let it breathe
With so much data locked away in documents and other unstructured content, now is the time to set it free. Finding and extracting that data, then storing it into a place where you can manage it in a controlled and structured fashion will not only make your processes more efficient, but it will also help you to understand what your business already knows.
2. Improve the quality of your existing XEVMPD data
XEVMPD is the first step towards IDMP. If you can manage your data well in XEVMPD format, then when the day to migrate to IDMP finally arrives you will already be able to understand and consume the new, additional, information.
3. Introduce smart business processes
In the past many business processes have been introduced in reaction to something bad that has happened. This breathing space means that you can now turn things around and perform a proactive review of your processes. By starting to think now about where IDMP data will touch your processes you can make sure that it is accessible, clean and ready to use before the guidelines arrive.
4. Eliminate inefficiencies and increase transparency
Across the industry we have enough duplicate data to fill a canyon. Now is our opportunity to slim that down and remove inefficiencies in our data capture, storage and reporting processes. By better understanding the underlying data we can more quickly answer common questions, such as “how many registrations do we have?” and “what does this drug treat?”
5. Use the time you have been given productively
By nature we're all the same. Given extra time to do something we all leave it to the bitter end and then rush to complete an average job, exactly on the given deadline. By delaying IDMP within Europe, the EMA has given us all an opportunity to get ahead of the curve. We know what is coming so we should use that time to move forward with plans, implement new processes and learn from mistakes before those errors cost us in real money through fines and lost revenue.
At the end of the day the new European pharmacovigilance legislation may be driving our actions, but there are so many more benefits beyond just compliance. We are talking about things such as control over information, key performance indicators and powering-up your workforce. We are talking about reusing what has already been done. We are talking about saving time and money by reducing time-to-market. And we are talking about increasing efficiencies by merging together the worlds of regulatory affairs, pharmacovigilance, manufacturing and clinical into a single managed solution.
Additionally, SPOR will go live in October 2017 and the industry will have access to O&R data. Industry stakeholders can start registering their super users and start using RMS and OMS from October.
How to go ahead with IDMP now? Waiting for further advice from EMA, or acting according to the principles of the IDMP architects?
Our recommendation is to stay on your pathway to IDMP but to shift your focus from “how to become IDMP compliant” to “how can we gain more efficiency, how can we achieve effortless compliance and how can we get IDMP compliant while not needing to think about IDMP compliance.”
For more information on IDMP technologies, best practices and implementation approaches come and talk with us at EXTEDO. We will guide you to Effortless Compliance™ and ensure that when the day finally arrives you are ready to hit the IDMP road running.