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Essentials of Safety Medical Writing

Everything you need to know to effectively write safety reports.


概要

Good writing begins with good planning, whether you are at the beginning of clinical development or working on an approved medicine. In recent years, there has been an increasing demand for regulatory documents focusing on patient safety. The requirements for safety reporting are similar worldwide and share the necessity for the writer to effectively distill the risk and benefits of the medicinal product. To successfully manage these reports, safety medical writers must be able to understand the principal scope of the pharmacovigilance (PV) documents that are relevant during the medicinal product lifecycle. Equally important to delivering a succinct summary is effective collaboration with safety professionals, which requires special consideration and analysis of the data to clearly communicate the key messages and findings for a given report.

何を学ぶか

  • Introduction of PV documents from beginning of clinical development until the withdrawal of marketing authorization
    • DSUR 
    • BLAs/MAA Clinical Summary of Safety
    • RMP
    • PBRER/PSUR/PADER
  • "Safety concerns" vs "Signals" two concepts at the core of global safety reports
  • Overview of relevent data and data sources from clinical trial data to spontaneous reporting
  • Safety writing skills: develop key messages: what is the story over time?

参加対象

This course is designed for professionals working in:

  • Drug safety/pharmacovigilance in R&D, post-market
  • Safety risk assessment, benefit-risk assessment
  • Risk communication
  • Medical writing
  • Aggregate reports writing team
  • Medical communications
  • Clinical/medical
  • Clinical informatics, data science, and statistics
  • Epidemiology
  • Regulatory affairs
  • Product labeling

学習目的

At the conclusion of this activity, participants should be able to:

  • Explain the basic principles of key PV documents
  • Identify the relevant data sources and focus on key messages relevant for each report
  • Analyze data in a structured way to determine relevant information
  • Develop key messages based on data review
  • Create reports that meet the needs of your audience

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