Revolutionizing Pharmaceutical Reporting through AI Technology
A new collaboration is set to transform the pharmaceutical industry’s adverse event reporting process by leveraging generative artificial intelligence (AI). SK C&C has announced a partnership with Ilsung IS (formerly Ilsung Pharmaceuticals) to utilize its enterprise AI solution, ‘Solur’, in creating an AI-based system for pharmaceutical adverse event reports.
Introducing Efficiency and Savings
Founded in 1954 as the first to introduce antibiotics in Korea, Ilsung IS is aiming to enhance efficiency and reduce costs across its operations by implementing hyper-automation through generative AI, cloud, and big data technologies.
Adapting to Regulatory Requirements with AI
The adverse event reports, vital for sharing undesirable or unintended signs, symptoms, or diseases associated with medication use, are mandatory for pharmaceutical companies to submit. These reports vary from a couple to dozens daily. The AI-enhanced ‘Solur’ rapidly organizes and formats these reports to meet the requirements of regulatory bodies using templates from the Korea Adverse Event Reporting System (KAERS) and the Council for International Organizations of Medical Sciences (CIOMS) for international reporting. The AI system is designed to facilitate reports from healthcare professionals and patients alike, converting and organizing them into specialized pharmaceutical terminology.
Planning for a Broader AI Utility in Pharmacovigilance
Both companies intend to extend the use of ‘Solur’ in various drug-monitoring tasks, developing a drug safety AI platform linked to a safety database (DB) in a cloud-native environment.
Future Global Expansion and Continuous Support
Additionally, SK C&C is firm in its commitment to support Ilsung IS’s system-wide operations by harnessing AI and data using ‘Solur.’ This partnership marks an opportunity for expansion into the global pharmaceutical markets, with ambitions set for Japan.
Officials Express Their Vision
Enthusiastically, an official from Ilsung IS shared how their adoption of ‘Solur’ aligns with their ongoing efforts to introduce AI into new business areas in pharmaceuticals. SK C&C’s executive commented on the potential for generative AI to minimize adverse event risks and create a safer environment for medication usage, pledging to actively support Ilsung IS in achieving a highly automated pharmaceutical operation that remains flexible in a shifting market.
Enhancing Data Accuracy and Anonymization in Safety Reporting
The application of AI in pharmaceutical safety reporting not only introduces efficiency but may also improve the accuracy and consistency of the data captured. AI systems can be trained to recognize and reduce human error that may occur during manual data entry. Additionally, AI can assist in the anonymization process of reports to protect patient privacy, which is crucial for compliance with data protection regulations like the General Data Protection Regulation (GDPR).
Identifying New Insights from Adverse Event Data
By applying advanced AI techniques to adverse event reporting, companies can potentially uncover new insights into drug safety. AI algorithms can analyze large datasets to recognize patterns and correlations that would be difficult for humans to detect, leading to a better understanding of adverse events and possibly contributing to drug development and safety.
Key Challenges and Controversies
– Data Privacy and Security: Integrating sensitive patient data with AI raises concerns about privacy and security. Companies must ensure that AI systems comply with strict data protection regulations.
– Accuracy and Reliability: The validity of AI-generated reports is dependent on the quality of the data and algorithms used. There are concerns about the potential for AI to propagate errors if not properly trained or monitored.
– Regulatory Acceptance: Regulators must be convinced of the reliability and validity of AI processes before AI-generated reports are universally accepted.
– Job Displacement: The automation of reporting could lead to job losses, creating socio-economic challenges.
Advantages of AI in Pharmaceutical Safety Reporting
– Increased speed and efficiency in adverse event reporting.
– Consistency in reports and reduced human error.
– Potential cost reductions from automated processes.
– Ability to process and analyze large volumes of data for better safety insights.
Disadvantages of AI in Pharmaceutical Safety Reporting
– Initial cost and complexity of setting up AI systems.
– Risk of job displacement for professionals in pharmaceutical reporting roles.
– Uncertainty about the ongoing maintenance costs of AI systems.
Related Links:
For more information on the topic of pharmaceutical safety and adverse event reporting, interested individuals can visit the following websites:
– U.S. Food and Drug Administration (FDA)
– European Medicines Agency (EMA)
– World Health Organization (WHO)
Please note that while AI offers a potential for bolstering pharmacovigilance, the implementation of such technology must be handled with care to ensure it aligns with all necessary standards and regulations. The transition to AI-assisted systems also requires continuous oversight to maintain the integrity and accuracy of safety reporting.
The source of the article is from the blog reporterosdelsur.com.mx