By: Romuald Braun - Vice-President of Strategy for Life Sciences, Amplexor
Introduction
The EMA’s IDMP may be the first digital requirement for life sciences but it won’t be the last. Companies looking to maximize their return on investment as they switch to data-driven processes need to create a flexible system that can meet every eventuality. Romuald Braun, VP of Strategy for Life Sciences at Amplexor, sets out a blueprint for future-proofing your system.
The EMA’s IDMP is set to become mandatory in February 2023, in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. But rather than thinking of it as a threat, companies should see it as an opportunity to do things in a smarter and more coordinated way.
The FDA in the US has long fostered similar goals linked specifically to labeling and CMC information management in pharma, with plans to extend its implementation of the ISO data standards to other areas, while other regulators worldwide are also looking at something like IDMP. At the same time, medical device regulations such as the EU’s MDR and identification standards (eg UDI) are progressing for medical device manufacturers – and who knows what else lies over the horizon?
It seems clear where everything is heading, even if many of the details are still evolving. What all of these emerging standards have in common is support for new digitally-enabled process efficiencies – across functional/company and even country boundaries – and for greater transparency and accessibility of product information.
It would be a mistake to invest in each set of regulatory requirements individually. This would risk incurring great expense – not to mention investment of time and resources – only to create another system silo, a scenario that is at odds with the data-driven movement.
The smart money will be spent on preparing not just for a given set of external requirements, but for a data-driven future that will better serve internal operations and – ultimately – produce better outcomes for patients.
Continuous Collaboration
Typically, companies still approach regulatory applications and reporting sequentially – documents are built, typically from scratch each time, through a painstaking process involving each department gathering its information before throwing it over to the next team to add their contribution.
EMA’s target operating model for IDMP challenges this process head on. It requires that the originating data behind each dossier is submitted/made available at the same time, requiring much tighter synchronization and alignment of document/data management activity. This requires more continuous collaboration between teams in different departments to maintain a single, comprehensive and current representation of the truth from which all submissions, knowledge and insights flow.
A Sustainable Strategy
Although it is tempting to wait until all of the details of a particular regulatory mandate are finalized before making serious headway with data-based process transformation, this strategy is flawed.
For one thing, IDMP’s main purpose is as a transfer protocol for exchanging information between regulatory agencies and the life sciences industry – its primary use case was never intended to be as a model for an internal data repository to help companies function more optimally.
Life science organizations can free themselves from a perceived reliance on external decisions to progress their own process transformations. They can take the principles and templates from EMA’s implementation of IDMP and other regulatory initiatives as helpful blueprints. But, given how diverse the global regulatory landscape continues to be, and how regularly requirements are updated, a more sustainable strategy will be to keep internal data models independent from regulator-specific parameters. Ideally, a company’s own data model will be built with the scope and flexibility to address a broad range of requirements through simple configuration. The key is that this new, improved organization-wide capability will support the maintenance of up-to-date, high-quality data right across the product lifecycle.
Invest Once and Well
Most regulatory teams understand the need to think laterally about compliance projects, but up to now this hasn’t necessarily translated into a more holistic and forward-looking approach to their preparations. More often than not, companies continue to put off the inevitable until deadlines feel within reach and the specifics of each set of new regulatory requirements are known. At that point, speed is of the essence and the temptation is to do something ‘fast and dirty’ which does the job within the time left. Then, when requirements are updated, or another region goes its own way, teams have to return to the drawing board.
The smart approach is different. It prioritizes up-front preparation, so that the company invests once and well for all future eventualities. Instead of looking for a single, mandate-specific system that delivers what’s needed for one region’s latest requirements, it focuses on creating a comprehensive internal capability that captures and maintains everything in a standard way for the global organization. This master data and any linked, approved content can then be repurposed/reconfigured in any number of different ways for each new set of needs.
Through collaboration across multiple departments, and with backing from the top of the organization, this emerging approach establishes a comprehensive internal data model with a high level of granularity, which can be continuously developed and adapted with input from across the enterprise.
Future-Proof RIM
There is still time to build a future-proof data-driven regulatory information management (RIM) capability, if companies start now. The better the preparation, the more sustainable, reusable and valuable the resulting platform will be.
This is how we recommend building such a capability:
- Start with an understanding of the benefits of a ‘Smart IDMP’ approach, or multi-purpose platform/capability, and an appreciation/acceptance that this will require more investment and planning now than a single-purpose compliance system.
- Establish a baseline. Identify the relevant data the company has, any gaps, and the steps and processes that will be needed to improve and maintain it – collaboratively and in the context of the desired data model. This should be thought of both from an internal perspective, and in the context of evolving regulator expectations.
- Put a project in place, defining roles and responsibilities, and securing support from senior management to drive any necessary transformation to business processes, and even the organizational structure, to allow the new data-driven vision for RIM – and more – to be realized.
- Implement the desired data model, accommodating the requirements of IDMP and any other relevant regulatory demands, along with the supporting tools or platform to enable these to be combined with associated processes. Consider scope for extending this capability to encompass functions beyond the Regulatory remit – such as Quality/Safety/PV and labeling management. A configurable platform will ideally support a wide range of use cases, based on the same core data set.
- Establish appropriate data governance, reflecting interdependencies between roles and teams across the value chain, so that the quality of data can be built across departments. This may require change management to support a revised/optimized organizational structure.
- Go live, ensuring that a data governance and associated process body is in place to maintain this valuable utility in a sustainable way, supporting continuous improvement to data quality and to processes.
If your company wants to avoid compromising its vision, the time to make the change is now.
About the Author
Romuald Braun is VP of Strategy for Life Sciences at Amplexor. He holds a Master’s degree in Drug Regulatory Affairs, an Engineers’ diploma in Data Technology, and has spent almost three decades working in compliance, document management and content management-related roles in this industry – in client-based as well as consulting and project management roles. Website: www.amplexor.com, Email: [email protected]
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!