Artificial intelligence (AI) is transforming a wide range of industries, and the field of regulatory writing is no exception. The use of generative AI can revolutionise the way medical and pharmaceutical companies address compliance challenges. In this article, we explore how generative AI is changing this industry, what tools are now available, and the implications for businesses.
1. What is generative artificial intelligence?
Generative AI is a subcategory of AI that creates new data that looks like an input dataset. In the context of writing, this means creating texts that can follow predefined guidelines and parameters, such as those required in regulatory documentation.
2. Automation and efficiency
Automation is one of the main advantages of using generative AI in regulatory writing. The software can generate draft documents that comply with the guidelines, thus allowing the medical writer to focus on more complex and specific tasks.
3. AI tools available for regulatory writing
There are various tools on the market, such as document management platforms and text generation software, which can be adapted for regulatory writing. Many of these tools offer machine learning capabilities that can be customized to a company’s specific regulatory needs.
4. Consistency and precision
AI can analyse huge amounts of data and guidelines to ensure that the documents generated are not only consistent but also accurate. This is critical in an industry where a small mistake can lead to legal and safety implications.
5. Adaptability to local regulations
Thanks to machine learning, AI systems can be trained to comply with the specific regulations of different markets, including Italy. This is particularly useful for companies operating internationally.
6. Ethical limitations and challenges
Despite the advantages, the use of AI in regulatory writing also raises ethical and practical issues. Responsibility for compliance remains with humans, and companies need to develop an ethical framework for the responsible use of AI.
Generative artificial intelligence has the potential to revolutionise regulatory writing in the medical and pharmaceutical sector, but it also poses technical, and, in some cases, ethical problems. A well-considered strategy for implementing AI can lead to greater efficiency, accuracy, and compliance.