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The adoption of structured, digital content for pharmaceutical regulatory submissions and product labeling is a significant change for life science companies—especially for smaller organizations, whose regulatory processes have been traditionally focused on detailed paper documents and unstructured data for compliance purposes.
It is becoming increasingly important from a safety and regulatory perspective to have efficient ways of tracking and distributing new data to the proper audience. Whether via portals, automated information distribution or other solutions, it’s critical to provide real-time accurate labeling information to labeling teams and healthcare providers as soon as a product change is approved by regulators.
In this conversation with Pharma Commerce, Cham Williams, associate director of business systems at IQVIA, shares his insights into how electronic standards are becoming the status quo; the technology needed to support this continued shift; and how these new solutions will minimize risks associated with regulatory compliance and increase patient safety.
Cham Williams: 1. An important part of the regulatory function is labeling of medications and ensuring that all information distributed from global headquarters is compliant and consistent when used at the local affiliate level. With products in multiple markets, companies must be able to react quickly to change. It has been a challenge to ensure that each local affiliate can quickly access information, understand the “why” and impact of a change and then ensure it is properly accomplished. Technology can help firms plan and track this process and provide greater functionality in that regard.
2. The pandemic put further emphasis on pharmaceutical companies adopting technology solutions as a means of streamlining the labeling process and we expect that to continue to increase.
1. Moving from document-centric regulatory processes to component-centric authoring for submissions is a significant change for life science companies. The process has been very document-centric up until now. And, while we started to see a shift to adopting a more electronic data submission process in 2021, the industry is poised to take it a step further.
2. In 2022, output by assembling these assets into documents for regulatory submissions and downstream labeling and marketing. The value of this structured content authoring method is that companies can take existing information and quickly generate forms of media on various solutions to distribute product and safety information efficiently and easily.
1. As noted above, moving towards technology that centrally coordinates the labeling information management and transitions from primarily document-centric processes to structured content authoring processes pose significant challenge for these companies. Not only do companies need to deploy solutions to enable a shift away from document-based submissions, but they must also ensure that users and stakeholders at the company adopt the new processes to ensure the maximum potential of these new solutions.
2. More so than other industries, life science and pharmaceutical companies have been leveraging document-centric processes far longer than most. Globally, health agencies have focused on transitioning from receiving paper-based documents to electronic documents. However, there is now a shift towards receiving structured data components. So, the shift to electronic-centric processes can be more significant from a user adoption perspective than from a technology perspective.
1. Understandably, smaller companies have found themselves cobbling together solutions to meet their labeling needs as they mature. And so, the ideal initial approach is to adopt scalable top layer technology that coordinates and supports the existing labeling process through all those existing solutions. As the organization grows it can replace existing ad hoc solutions with functionality inside the top layer solution.
2. In addition, natural language processing (NLP) capabilities can assist with the main portion of the content as it helps in making information available at the local level.
3. When NLP is combined with AI, it can also enable additional support, providing the context of the safety impact that a direct translation may miss. Looking ahead, the use and adoption of these technology solutions will greatly increase, providing efficiency and regulatory compliance.
As we’ve seen across most industries, the pandemic forced business leaders to rethink all of their digital strategies and approaches. While shifting away from document-centric processes reflects a significant transition for most life sciences companies, health agencies understand the needed change and the benefits of the transition and are encouraging companies to adopt technology by implementing regulations that necessitate digital capabilities.
1. We will see these technologies become table stakes for larger and more innovative life sciences companies. As these organizations exhibit the returns and benefits of adopting these new technologies, others will be comfortable to follow suit.
2. The ability to plan, track, create and distribute pharmaceutical product information consistently and quickly using labeling technology will directly impact patient safety. Pharmaceutical companies are not immune to the expectations of being socially responsible companies and by ensuring the information available to patients is real and accurate in a variety of mediums will go a long way to instilling confidence in the marketplace.