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Essentials of Safety Medical Writing

Learn how to effectively plan, write, and communicate key safety information in pharmacovigilance documents while collaborating with safety professionals to ensure clear and impactful regulatory reporting.

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Overview

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. Effective collaboration with safety professionals is equally important to deliver a succinct summary, which requires special consideration and analysis of the data to clearly communicate the key messages and findings for a given report.

This on-demand course will equip you with the essential skills to write clear, effective, and compliant safety medical documents.

Featured topics

  • Overview of pharmacovigilance documents
  • The DSUR
  • Submission
  • The Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
  • Periodic post-marketing safety reporting (PBRER/PSUR/PADER)
  • Safety writing skills

Who should attend?

This course is designed for professionals involved 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

Learning objectives

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

  • Identify the basic principles of key pharmacovigilance documents.
  • Recognize the relevant data sources and key messages relevant for each report.
  • Analyze data in a structured way to determine relevant information.
  • State how to develop key messages based on data review.
  • Describe ways to create reports that meet the needs of your audience.

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