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.

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• 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