The Future of Regulatory Automation: Implementation Considerations for AI in Regulatory Operations
New tools using new artificial intelligence (AI) are?almost ready for prime time?and despite the industry’s initial reluctance to embrace it, regulatory teams are being inundated with new, AI-assisted tools for improving regulatory compliance. But with a machine-first mindset comes the development team’s commitment to real-time evaluation of data.?AI and machine learning tools?are poised to bring better outcomes to patients, payers and stakeholders.
Despite an initially low uptake, some major pharmaceutical companies have already invested in?AI tools?to automate the analysis of regulatory documents. These programs range from simple automation tasks to the use of AI technology leading a fully supervised review system. These applications can streamline various processes, improve efficiency and accuracy, and provide valuable insight and analysis, including:
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Read our full blog to learn about key considerations for implementing regulatory automation to ensure success.
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Clinical trials professional
1 年I am still skeptical , as it is we are trying to go paperless at clinical trial sites which means control is handed over to IT department, at Phase 1 , where the regulations needs to get stricter , if You condition AI properly you will end up in a situation where all the private funded sectors can get through the loop holes and leave the federally funded genuine public health research penniless at the mercy of partnering with big pharmas. This is not good for federal funded projects trying get a product out on market. Atleast it’s not going to work in Australia where phase 1 regulations need human intelligence not automation , may work on phase 2 or 3, not on phase 1 after HERC approval the tap is in phase 1 and so is the control on which pharma products can go to phase 2 , and Australia’s ???? brand is Safety first . Not for Australia for phase 1 , may work in America , because we don’t have FDA here to rely on safety, wherever there interest lies. Thankyou ??
Localisation specialist | IKEA
1 年I'd argue that expert assessment is also necessary for the translation of lay summaries. It is important to underline that LLMs are biased toward English and high-resource language pairs. Moreover, the task of writing or translating lay summaries is complex and nuanced, as it involves adapting content to suit the cultural context of the target audience. This means that the information contained in lay summaries can vary greatly from culture to culture.
Project Manager at ICON Strategic Solutions
1 年AI is a power tool but must never replace human intelligence.
LDM
1 年AI and Machine learning is the Future
Bioinformatician
1 年It's very interesting!