Find out how life sciences manufacturers and marketing authorization holders can reduce the maintenance burden and mitigate the risk of registration delays.
As the role of data moves front and central to regulatory processes in Europe, life sciences manufacturers and marketing authorization holders need to be very clear about what their new processes will be. Not just for capturing the required data for registrations, but also for keeping it perfectly in sync with the information in dossiers, and for maintaining and updating this over time.
There are two priorities here: (1) achieving complete data confidence (eg that the master source is always accurate and in sync with what’s included in documents; and (2) doing this in the most efficient and sustainable way possible on an ongoing basis.
Post IDMP, data & document content must match to avoid registration delays
Before now, no one really cared how structured or not the content in submission documents has been. Any later data logging or archiving has typically taken place post-approval, based on an agreed registration. It has not had a direct bearing on authorization success or progress.
But in the new IDMP era, which initially will see data submitted in parallel with dossiers – eventually forming the primary vehicle for information exchange, registration and lookup – the stakes are much higher. The quality, completeness, accuracy and currency of data – and its consistency with what’s documented – will have a direct bearing on the status and timescales of registrations. If what’s published doesn’t perfectly match the SPOR data, queries and delays will follow.
Effecting change: the devil’s in the detail
The most effective and efficient way to ensure a continuous match between data and documents is to manage the two as a continuum, harnessing techniques and tools such as text mining and structured content authoring to achieve content parity – and to convert one format intelligently into another while protecting its integrity. But what’s involved in getting to that point?
It’s a subject I’ll be exploring in a new practical guest webinar hosted by Amplexor in a few days’ time: ‘Unlocking the business benefits of text mining in regulatory operations’.
I’ll be looking at some of the practical preparations companies can make now so that teams are not caught out once the requirement for upfront data submissions becomes standard practice.
Don’t be caught out
Unless teams iron out the details now, assign responsibilities, and figure out exactly what their new processes will be, how they will work in practice, and what the data flow and maintenance activity will look like, there is a risk that issues will emerge during business-as-usual. That might be during the first variation submission once the new IDMP/SPOR-based target operating model is active and mandatory. And by then it will be too late – the consequences of ill thought-out processes and systems will be real.
In the webinar, I’ll be reviewing companies’ practical options for achieving closer alignment between data collection/data flow and document creation, and the pros and cons of those alternatives.
There’s a lot to talk through. I hope you’ll join me on the 21st.
About the author
Kelly Hnat is a principal at K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations. She has over 25 years' experience in the biopharma industry leading IT, RIM, and Regulatory Operations organizations in several companies. Kelly serves as a subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub-team, and the SPOR EU Implementation Guide Focus Groups. She is also on the Core Research Team for the Gens World Class RIM survey and serves as President of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards.