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. 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.

What you will learn

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?

Who should attend?

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

Learning objectives

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

Digital Learning Catalog

Download

Have an account?