The regulations worldwide require pharmaceutical firms, biopharmaceutical companies, and marketing authorization holders (MAH) to report all adverse events (AE) for which there is a reasonable possibility that their medication caused the event. Yet, sponsors and manufacturers often are cited for not being in compliance with these regulations. The process requires a critical attention to detail, well-written protocols and standard operating procedures (SOPs), and concise, audit-ready reporting. This course will also address the current adverse events report format and content for non-approved medicinal products (Drug Safety Update Reports – DSURs). A sample DSUR will be provided. The newly-required Periodic Benefit-Risk Evaluation Report (PBRER) and content will be discussed. Any differences between the US and EU requirements will be highlighted.
This webinar will discuss how you can run a compliant, efficient AE reporting program.
By attending this 90-minute interactive session, you will:
- Gain the foundation to build a compliant program while avoiding common pitfalls
- Understand differences in reporting requirements between the U.S. and EU
- Learn the critical parts of the process – from laying out SOPs through report writing