Data-driven, IDMP-based regulated product data and submissions management is a long journey, and companies won’t reap the benefits of their preparation efforts for some time yet.
The journey to data-driven, IDMP-based regulated product data and submissions management is proving a long one for the life sciences industry, and it will take some time before companies can reap the benefits of their preparations for data-first information management.
But this is no reason to limit ambitions. As someone once wisely said, ‘Blessed are those who plant trees under whose shade they will never sit’: meaning that sometimes you have to invest in a better world for future generations even if the benefits won’t be felt in the near term.
A lot of the work required towards IDMP today fits into that category. The fruits will be abundant, even if the harvest may be some way off. For now, there is a lot of planting work to be done and there is no time like the present, given the recent release of the latest guidance (IDMP Implementation Guide v 2.1) in Europe.
And, actually, many of the base preparations have already been made – along the way from eCTD-based submissions and more recently to xEVMPD database compliance. So there is good experience to draw on, both internally and from supporting partners, which will help create the right conditions for success.
So what’s standing in the way?
Preparing the ground is demanding work
Up to now, documents have taken precedence over data in regulatory processes – a scenario that will be reversed under IDMP. In the future, data will be treated as the primary resource and source of truth, with any documents being secondary – and ideally created dynamically from a rich set of accurate and up-to-date master data.
A data-driven approach to managing content requires a robust, continuously-evolving, single source of product truth. From that, all process improvements can follow – from largely automated, structured authoring of content, populated by definitive, up-to-date, approved information; to better outcomes for patients as they and their clinicians across Europe are able to call up the latest, standardised information about any medicine online.
Of course, getting to this exciting end point requires that all of the right conditions are established, and this has been the issue up to now.
Most palpably, there has been a hiatus as EMA honed and confirmed the specifics of how data will be categorised and formatted for IDMP. But this is not the only hurdle for companies to overcome as they reconfigure their ways of working to emphasise live RIM data over static documents.
Crop rotation: data-driven processes are more fluid
Practical challenges include overcoming internal silos and fostering new interdepartmental relationships and collaborative habits: those that will promote the creation and maintenance of a definitive, high-quality data resource that can feed into all Regulatory activity in the future.
Certainly there will be a steep learning curve as teams regroup, establish a reliable information baseline, and familiarise themselves with the new IDMP submission system. This will be a full-scale change management exercise, as whole departments adapt to a world in which data assumes prime position and paper or PDFs provide the secondary snapshot.
But as processes bed in and the next wave of manufacturing updates creep in, teams will experience the first sense of the new ease of managing information and content – now with a single central place to revise the data; changes which can be automatically cascaded down to a wide range of use cases, including global product labelling.
Maximising future yields: process dynamism & job diversity
Once companies have switched their mind-set and regulatory processes to a scenario in which data is the primary focus, they will be able to build all kinds of efficient and reliable automation processes into the way they create and file submissions, and generate use-specific documents.
As well as reducing repetitive work, and associated risk, the changes to people’s roles and working relationships will be transformational.
Bob, currently in charge of drug product specifications in Regulatory CMC, will no longer have to worry about the accuracy and compliance of content that has been compiled manually: in future this will flow in directly from Supply-Chain Sally who is now responsible for maintaining, updating and refining the definitive master data. From this, Bob’s documentation will now be generated automatically.
These streamlined scenarios should all be part of companies’ IDMP planning and planting cycle, promising many tangible benefits for the business in the fullness of time. Companies just need to realise that preparing the ground – breaking down departmental silos; creating robust, complete and high-quality data; and establishing new multi-disciplinary workflows – is likely to take a period of years, and gather their reserves accordingly.
About the author
With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.