Digitalization opens new opportunities for pharmacovigilance

Due to continuously expanding market and regulatory constraints, industries have been forced to re-evaluate their safety operations and how they affect operating costs, productivity, quality, audit, and compliance.

Pharmacovigilance must be integrated into a pharmaceutical company’s daily operations for it to be effective. Pharma businesses revolutionize the entire PV process by leveraging technology. Automation is the initial stage in the transition of PV.

Document Intelligence

• Pharmacovigilance activities access a huge amount of varied, dynamic, dispersed, structured, or unstructured data, which presents hurdles in terms of its interpretation due to its complexity, content, and scale.
• Traditional methods are frequently insufficient for processing the volume of data that is so huge and complex since no actions can be taken on the gathered data without a structured generated document.
•   Artificial intelligence technology with smart documents and reporting capabilities could be a potential answer to all of this. Such solutions can assist PV professionals in creating templates and streamlining the material so that, when necessary, the necessary data can be fetched in only a few seconds.
•  It helps to produce data-driven documents because it can process several data sources at once. These systems require fewer people to pull data each day because they have the functionality to interact directly with data sources. It is easier to evaluate the data as and when needed by creating templates that are appropriate to the data and needs.
•  Conventional data sources have been used as the main data sources for gathering patient safety information on pharmaceuticals and clinical trial outputs. However, none of these by themselves can be used to establish the full safety profile of a product.
•  Entering the world of big data and concrete proof is therefore vital. By incorporating numerous social media platforms, claims data, electronic health records, wearable platforms, and more, it has greatly increased the number of data sources.
• Although these new data sources offer helpful information for recognizing safety signals, it takes a lot of effort to process the vast amount of data they produce.
•  According to the FDA, only the highest quality data should be evaluated and reported. PV professionals may develop reports that are specific to a certain market niche because of the smart document flexibility of AI platforms.
• Based on conditional logic built right into the document design, they can choose to display or conceal the data. As a result, it takes less effort and money to provide customized and segmented reports.
• Therefore, the digital revolution brought about increased computer skills that sparked the attention of regulatory agencies, pharmaceutical companies, and researchers in using big data for monitoring medication safety and smart capabilities for creating papers and reports.

Document Digitization in Pharmacovigilance

• Document digitization is the first benefit of automation in the PV industry. According to statistics provided by the WHO, drug side effects are the fifth most common cause of mortality. Therefore, pharmacovigilance is essential because modern patients eagerly anticipate learning more about the safety of drugs and treatments.
•  Companies are required to consider the information on AE from numerous data sources, including chatbots, public forums, social media, and other channels, following the new legal standards.
• The number of data streams has significantly increased because of this need, which has inevitably resulted in a rise in the amount of data being transmitted.
• The range of adverse event data and the requirement for analysis have led to a complicated PV process. Separating genuine crisis cases from alerts takes a lot of time amidst the data flow.
• Pharmaceutical companies must meet regulatory requirements for the integration and management of enormous amounts of data that are used for the evaluation and processing of drug safety information, in addition to the pressure brought on by the market’s production of data.
• For stakeholders in the pharmaceutical industry to meet these standards, document automation systems must undergo significant modifications.
•   The document automation system not only speeds up the documentation process but also enables PV specialists to create visually appealing documents that incorporate all the data logic directly into the template.
•  Adverse events spiral out of control because of the slowdown in signal detection. Document automation is the only way for organizations to efficiently handle such a massive collection of data.

Automation for Analyzing Adverse Outcomes

• Adverse event processing is the main objective when it comes to automating PV operations. Pharmaceutical industries spend a significant amount of time, money, resources, and effort to carry out this repetitious procedure properly.
• The case management procedure in PV is already largely automated. When compared to manual submission of forms, this has increased the quality of submissions. Additionally, electronic submissions happen on their own and don’t affect the schedules for regulatory reporting. Therefore, the impact of AI applications in PV on the effectiveness and efficiency of the work is also anticipated.
•  The degree of automation in case processing depends on a variety of factors, including the volume of cases, the number of phases in the case processing workflow, and more. This renders some of the manual processes unnecessary.
•  AI can be used to make the case intake process even simpler. This can make use of both machine learning (ML) and natural language processing (NLP) ideas.  

Cloud-Based Pharmacovigilance Solutions

• By keeping a sizable amount of data in the cloud, numerous sectors have profited. The pharmaceutical sector has experienced a boom because of the necessity to maximize data intake, store it, and then analyze it.
• An expanding number of data sources are now adding to our understanding of the advantages and risks of pharmaceutical goods.
•  Big data applications for pharmacovigilance have become relevant with the rise of cloud technology. Pharmaceutical businesses will need technologies that are effective to handle the enormous number and diverse data sources surrounding adverse drug reactions to make educated decisions in PV.
• To provide regulators and those in possession of marketing authorizations with knowledge and valuable information, big data output must be integrated and unified. At the patient or public health level, it can aid in the prevention of severe ADRs.
• With the help of this large amount of data, the owners of marketing authorizations can defend the market position of their medications.
• Pharmacovigilance software suppliers are anticipating being able to offer extremely customized and durable solutions that guarantee data security. Users may easily employ signal detection and data analysis approaches as more and more pharmacovigilance data is moved to the cloud to be evaluated.
• Additionally, the ability to always access the most recent version of pharmacovigilance software without the need for in-house installation will contribute to its wider acceptance.

Results and Discussion

• Due to document automation, artificial intelligence, and cloud technologies, pharmacovigilance tasks have already undergone a major revolution.
• Each new generation of instruments will also improve intelligence and adaptability, expanding the scope of applications to creatively tackle fresh pharmaceutical challenges.
• The regulatory bodies and the pharmacovigilance firms are aware of the potential for PV with these technologies.
• Some pharmacovigilance procedures, such as case entry, case processing, and reporting activities, are automated using modern technology.
• Individual case safety reports (ICSR) can be less time and money-consuming for businesses, freeing up resources for proactive risk assessment, identification, and mitigation.
•   By implementing technologies like document automation, AI, and cloud-based solutions, pharmaceutical companies can advance toward end-to-end automation across the PV spectrum.

Students at Sollers College receive education about the regulatory roles that pharmacovigilance plays and how those roles are operationalized.

Students are equipped with the fundamental knowledge and practical skills needed to meet the demands of the expanding healthcare industry.

 By gaining knowledge of the necessary abilities, you can build a fulfilling profession. Your learning is aided by an all-encompassing program that is in line with Soller’s College. 

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