AI in Regulatory Medical Writing-Opportunities and Challenges

3:30 PM - 3:45 PM

The momentum behind adopting innovative AI-driven systems in the pharmaceutical industry is growing stronger by the day. While initially challenging, exploring these systems for medical writing has sparked a wave of innovation.

Result-containing documents like Clinical Study Reports (CSR), and other submission documents are authored manually, which is a time-consuming activity. In addition to inefficiencies for both writers and reviewers in creating routine content based on personal preferences, there are also inconsistencies associated with the manual process leading to extended timelines. Modern natural language generation (NLG) capabilities strictly regulated for accuracy and consistency will help augment medical writing activities and increase efficiency.

During this session, we will discuss the application of rules-based AI for regulatory writing, for documents such as study reports and clinical summaries. Through case studies and examples, we will highlight benefits and challenges of adopting AI in regulatory writing practices. We will explore how AI is redefining existing roles, empowering professionals to concentrate on strategic authoring while repetitive tasks can seamlessly be managed by technology.