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Blog
Technology's role in labeling and regulatory additional risk minimization measures (aRMM)
Cham Williams, Associate Director, Safety, Regulatory and Quality Customer Engagement
Feb 04, 2022
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  • Technology's role in labeling and regulatory additional risk minimization measures (aRMM)

As with other aspects of life science company operations, labeling is benefiting from various technology solutions such as automation, Artificial Intelligence (AI)/Machine Learning (ML) and Natural Language Processing (NLP), especially in the area of reducing risk. Whether it’s a global pharmaceutical company or a smaller firm with only a few geographic distribution areas, each must be able to distribute information from headquarters to local affiliates as quickly and efficiently as possible to ensure data is shared properly with healthcare practitioners as well as patients and captured in labeling processes.

Automation technology helps to streamline the distribution of this material. That said, it is the NLP solution that really assists in the distribution of information across many languages. It helps to bring context into the conversation so that it is clear how the labeling changes impact the safety of the solution. AI technology takes it even further with its self-learning feature so it can learn and assist even more in the future.

In recent years, life sciences companies have been challenged with developing an effective cross-functional solution to manage the routines and additional risk minimization measures (aRMM) required to optimize the risk-benefit balance of a medicinal product. The aim of aRMM is to improve the “prevention or reduction of the occurrence of adverse reactions associated with the exposure to a medicine; the reduction of their severity or impact on the patient should adverse reactions occur”; or optimizing the benefit of a certain medicinal product.

The planning, development and implementation of an aRMM process, as well as the tracking and evaluating of its effectiveness, directly integrates with the end-to-end label processes. As regulations change in EMEA and around the world, it is becoming increasingly urgent from a safety perspective to properly identify the audience – HCPs or patients – and get the information directly to them in a measured and target manner. A clear framework is needed to create an optimal comprehensive approach to ensure success.

Whether it is via portals, automated information distribution or other solutions, it is critical to provide real-time accurate labeling information to the correct audience as soon as a change is approved. Technology is helping to increase the confidence of individuals receiving effective communications – ultimately helping to create an end-to-end label solution. While no one-size solution will fit the needs of all local affiliates, with a flexible, tailored approach of everything from a postage paid return mailer to a QR code, life science firms can be confident that the information is being disseminated quickly.

Where the challenge will arise this year and beyond is how the implementation of these solutions can occur from a planning and tracking perspective. Currently, it all relates back to the regulatory documentation at the global level, filtering down to the local level for compliance checks and then back to headquarters for a final review again. An end-to-end labeling process that includes all the points that labeling touches is needed to ensure proper compliance. While technology is key to the distribution of the information, this solution will incorporate understanding processes and regulations as well.

For more information, please visit the IQVIA RIM Smart page. For additional questions, please send an email to RegulatoryTechnology@iqvia.com.

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IQVIA Labeling Compliance Solutions
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Embracing Change and Dealing With It
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Optimizing Medical Device Product Change Workflows – Integrations Across Safety, Quality and Regulatory
By: Michael King, Kari Miller
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Data is the focus for regulatory submissions
By: Cham Williams
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