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This week, we examine the CIOMS XIV draft, “Artificial Intelligence in Pharmacovigilance,” and what it means for your organization.
What is the focus of the CIOMS XIV draft on AI in Pharmacovigilance?
The CIOMS XIV draft, titled “Artificial Intelligence (AI) in Pharmacovigilance (PV),” focuses on the integration of AI technologies in pharmacovigilance processes. It emphasizes the importance of applying quality assurance principles to human oversight of AI systems to ensure their reliability and effectiveness.
Why is human oversight essential in AI systems used in pharmacovigilance?
Human oversight is crucial because AI systems, while capable of delivering polished outputs, can sometimes produce inaccurate or misleading results. Professionals must challenge and verify AI outputs rather than blindly trusting them. This oversight ensures that AI systems are used responsibly and effectively.
What are the different approaches to human oversight in AI systems?
The three main approaches to human oversight in AI systems include:
- Human-in-the-Loop (HITL): Humans can intervene in every decision cycle of the AI system.
- Human-on-the-Loop (HOTL): Humans oversee the system design and monitor operations but do not intervene in every decision.
- Human-in-Command (HIC): Humans have ultimate control over the use of AI, including deciding when or if to deploy it.
How does human oversight optimize AI performance in pharmacovigilance?
Human oversight is key to optimizing AI performance because it ensures that AI systems are continuously monitored, refined and evaluated. This multidisciplinary teamwork approach helps build smarter pharmacovigilance systems by combining human expertise with AI capabilities.
What impact does AI have on the pharmacovigilance workforce?
AI in the pharmacovigilance workforce can streamline tasks, potentially reducing team sizes and sparking job concerns. However, AI is not replacing PV professionals; instead, it frees them from tedious tasks, allowing them to focus on innovation and expertise. Training is essential to equip professionals to monitor and evaluate AI outputs effectively.
What is the importance of training in integrating AI with human expertise in PV processes?
Training is the foundation that holds everything together. Thorough, well-designed and rigorously tested training programs are essential because AI is only as effective as the people who guide it. Professionals need to be equipped to monitor, refine and critically evaluate AI outputs to ensure the systems’ effectiveness and reliability.
Author
Dr. Vivek Ahuja serves as EVERSANA’s Senior Vice President for Delivery Excellence, Strategy, and Growth (PV, Quality, and Regulatory Services) with over 22 years of experience across multiple functional offerings including Pharmacovigilance, Clinical Research,…