Although the value of developing more data-driven processes is now widely recognized, many life sciences organizations today still routinely create critical documents and product labeling from scratch. This involves capturing and applying the same information repeatedly, yet often in different formats and using inconsistent terminology.
At Amplexor BE THE EXPERT 2022, Remco Munnik of Iperion – a Deloitte business took the example of product labeling to highlight the overlap between documents and data, and how internationally agreed standards can contribute to a more streamlined approach to (and beyond) regulatory information management — from early development through to pharmacovigilance.
If you think about it, most of the regulated data required under the Identification of Medicinal Product (IDMP), a suite of five pharmacovigilance standards developed by the International Organization for Standardization (ISO), appears on — or comes from — a product’s labeling. Much of that same information will be used in the preparation of dossiers and electronic submissions. In fact, from early product development right through to pharmacovigilance, all kinds of processes make use of a lot of the same information.
Because of this, it seems puzzling that so many organizations still manage each process discretely, maintaining their own information and content repositories and creating their documents from scratch each time. Not only is this inefficient, it also invites inconsistency and potential error — and it is inhibiting process transformation on a broad scale.
IDMP: the Transformation Enabler
Whatever bumps there have been in the road to IDMP implementation in the EU, the standards are increasingly tangible. Indeed, it’s now only a matter of time until the Regulator will be looking at the electronic documents being submitted alongside the data that they are based on and checking for consistency between the two sets of linked assets. If there are discrepancies — if the two have been created separately — this will soon become apparent, leading to queries, challenges, and potential delays to market authorization/approval of variations.
Although it shouldn’t take such concerns to spur companies into more purposeful action, this additional compliance/risk management driver does strengthen the case for investments in data assessment and preparation and ultimately in data-driven process transformation, such as electronic product information (ePI).
Look Laterally, Go Further
The real opportunity and higher goal remains one of transformation that transcends individual teams and departmental boundaries. It is about connecting and enabling reliable data flow between research and development, pharmacovigilance, supply chain, and other departments.
This starts with discovering which systems are in use in adjacent functions and to what extent these can be more closely integrated to enable meaningful data exchange. It then requires that the information in those systems is described in the same way — using the same substance names and product definitions. If/once they all conform to IDMP SPOR specifications and, better still, draw from the same data pool, the potential for consistent, end-to-end data management and repurposing is limitless.
It is an accepted fact that getting to this state of nirvana will require a lot of work (assessment and analysis, data remediation, integration, and ongoing data governance). However, once processes are truly data driven, especially by robust, consistent, up-to-date data, teams under increasing pressure will be better able to deliver more, and within less time, without adding more people.
A final note is the reminder that IDMP, whenever and however it finally lands, is by no means an exclusively European endeavor. For instance, the U.S. FDA has committed to run a series of data-driven pilots for global pharmaceutical product and substance identifiers. More broadly, the World Health Organization (WHO) has committed to work with the EMA and the FDA on global identifiers as the answer to problems exposed by the pandemic. Issues such as how to urgently address product shortages and availability of medicinal products will be easier to manage once global identifiers are in place.
The solutions (digital platforms, advice, professional services) are well within reach; companies just need to aim high. The benefits of pursuing data-driven process transformation will absolutely be worth it.
This article is based on a talk that was presented at the Amplexor Life Sciences Be The Expert conference in June 2022.
Remco Munnik is a director at Iperion – a Deloitte business. As well as being a respected subject matter expert in RIM, eCTD, xEVMPD, and ISO IDMP, Remco is an active member of the EMA ISO IDMP Task Force for Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice President of the IRISS Forum.