Being forced into teleworking has made us realized about lot of things. Things we can improve and ways of working we should change. But, what should we change? Is there any way to improve?
Several days ago, during a call with a customer, he told me:
“we need our systems to be connected. We have realized that everything is disconnected and we need to make a change in the way we are currently working”.
Until recently, the processes we followed have served us well. We had the information available in a more or less efficient way, and when we were asked to access to different data, we have managed it investing more or less time and resources.
Now, despite being closer than ever thanks to new technologies, we are actually further away and the information flows we have relied on for so long have had to change.
In point of fact, in the pharmaceutical industry, we have never had well-defined information or data flows. It is true that we have very well established processes for drafting, reviewing and approving documentation. But when it comes to data and information, there are no really robust processes.
We are seeing this now when we want to access these data and it is very, very difficult for us to have a reliable, up-to-date and secure source of information.
Data is the new oil, well treated it can bring a great value to the company, it allows us to take strategic decisions faster, analyze the impact of a certain change with more precision, etc.
However, how can we be confident that the data we have is up to date, reliable and accurate?
If one thing is clear, it is that health authorities such as EMA or FDA are beginning (or did long ago) to change the paradigm. For some time now FDA has been asking for all the raw data from clinical trials in the dossier (datasets) and EMA, for example, maintains a product database (xEVMPD).
But this is only the beginning. The IDMP project, led by the EMA, is the next point to focus on data. IDMP (Identification of Medicinal Product) is a big challenge for the industry. We will need to capture a large amount of data related to our registrations and send it to the new database being prepared by EMA. (Are we prepared to capture such a large amount of data?)
Apart from that, IDMP will not be implemented on its own, but it will come together with TOM (Target Operation Model). This will mean changes in the registration processes since the intention of the TOM is to make all these processes more efficient and to take advantage of IDMP in order to reduce efforts.
But why don’t we see the implementation of IDMP as an opportunity instead of an obligation?
Can you imagine having a platform where you have all the data from all your registrations, with defined flows to update the information instantly?
Can you imagine being able to access that information and generate reports with just a couple of clicks and from anywhere?
Can you also imagine being able to relate those records to the regulatory activities that apply to them?
All this technology already exists, it is in the market and there are already companies that are implementing this type of software. Not just big companies. Small and medium companies need to improve their processes and they have seen in this type of software an opportunity to do so. These softwares are known as RIMS (Regulatory Information Management System) and allow us to have all the data in one place, where we know it is reliable and concrete and we can also relate it, not only to the different regulatory activities that affect them, but also to other softwares within the company (document managers systems, publishing tools, SAP, etc).
IDMP is a reality.
Despite the delays in its implementation, due to other reasons than its complexity, there is little time left for us to incorporate it into our daily work.
Let’s make IDMP not just another piece of legislation, let’s take advantage of it. Because the potential it has is huge, and we can make it really worthwhile.
Marcos Fernández Gómez, Regulatory Affairs Associate Director
