Learn more about the business benefits of electronic product information and how to begin to scope the work required to reap the rewards of digitization.
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Health and regulatory agencies across the world are showing increasing interest in introducing standardized requirements for electronic product information (ePI). At the same time, patients and healthcare professionals are increasingly receptive to digital delivery of ePI. But the potential ePI offers life sciences companies to increase efficiency, decrease error and delay and accelerate time to market is perhaps the factor that is driving the digitalization of product information most of all.
Paper-based instruction leaflets to inform patients and healthcare professionals when and how to use medicinal products, and advise them about any safety considerations, are an anachronism in the digital world. More critically, paper-based product information or instructions-for-use can soon go out of date, either because new safety signals have been identified since the current batch of products went into distribution, or because devices have been sitting in a cabinet for months or years.
The solution: ePI
The ability to publish ePI online will relieve the pressure on paper-based information publishing – and all of the logistics involved, not to mention the potential for label/leaflet wastage each time information or messaging changes. Shorter change management/publishing cycles contribute to accelerated regulatory processes, resulting in improved speed to market with products, and strengthened continuity of supply. However, organizations must have streamlined and reliable means of managing and approving changes to content if they are to reap cost efficiencies.
The need to deliver electronic product information creates a robust use case for structured content, where companies can confidently assemble the latest, correct information (which has been approved for use), for the current purpose. If companies had a facilitating content management backbone extending from one end of the organization to the other, globally, and were able to work with approved core data assets which have been captured in a structured way and are using defined terminology, they would have the potential to transform the way they manage labeling – and publish changes online.
Transforming data to speed the lifecycle management
There are a number of steps life sciences companies must take before they can start capitalizing on ePI efficiencies. Successful transformation of label content lifecycle management will rely on improvements to content, technology, and processes. That is, any investment in technology to support digital transformation must be matched by measures to assess, connect, clean up and restructure current data sources; and new thinking about how information and content processes could be managed in future to drive new, more effective and efficient labeling strategies.
Companies should start to unify as much of their information and content preparation as possible, in accordance with regulatory requirements. Using the controlled vocabularies set out by electronic submission standards (i.e. xEVMPD in the EU, to be succeeded by the more detailed ISO IDMP-based requirements), they can start to impose improved consistency in the way regulated product information is constructed. This will help create solid content components or building blocks for all labeling. Also, an end-to-end regulatory information management (RIM) platform will play an important part, forming the backbone across which all active and historic content, along with associated status information, can be viewed and managed.
What’s the future?
Most life sciences companies are not ready for an ePI transformation. Their capabilities for publishing regulated content tend to be so constrained that larger companies typically outsource their labeling management requirements. It feels easier to send data and get print-ready files, than to contemplate transforming regulatory content management backbones to better support process innovation. Digitization offers real opportunity, not only to drive efficiency but also to add value through greater information accuracy, easier content validation, accelerated regulatory processes, rapid safety updates, and the phasing out of frequent print updates and the potential for wastage each time information changes.
Waiting for regulators to mandate change to (structured) electronic product information delivery will be to leave all of this too late. The path to digitization may be a gradual one, but there is no doubt that global markets are converging towards the same goal. That’s because agencies understand that continuing with current labeling practices and product information delivery is unsustainable from every angle - something companies already know deep down too.
About the author
Agnes Cwienczek has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management. Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization. She was responsible for implementing and maintaining the regulatory applications and data management strategy and roadmap, and ensure business operation of applications under her responsibility, and to lead a global team of regulatory operations experts. Agnes received her master’s degree in Information Management from the University of Koblenz-Landau.