Meeting the escalating global demand for new medications requires expediting regulatory submission development. Documenting drug safety issues occurring in clinical research is a major aspect of regulatory and medical writing. Two major types of safety regulatory documents are the development safety update report (DSUR) and the patient safety narrative.
This webcast will discuss the latest regulatory requirements changes and artificial intelligence technology advances in drug safety reporting. The DSUR summarizes the safety information occurring during the clinical development of an investigational drug. Regulatory professionals in the pharmaceutical industry are often unaware of the recent changes in regulations that affect the country-specific requirements for DSURs. Recent examples include the EU requirements in the clinical trial regulation. China, the UK, and Canada have new requirements too. This webcast will summarize these regulations and highlight potential DSUR changes by the US Food and Drug Administration (FDA).
Learning Objectives
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- Understand the country-specific DSUR requirements released over the last year
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- Understand how this impacts the content/structure of the DSUR
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- Appreciate the potential upcoming US-specific DSUR requirements
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- Understand recurring challenges in patient safety narrative projects
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- Appreciate the potential of generative AI technology to facilitate narrative writing
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- Compare traditional solutions vs tech solutions for drug development