Worldwide regulations 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 complying with these regulations. The adverse events reporting process requires critical attention to detail, well-written protocols and standard operating procedures (SOPs), and concise, audit-ready reporting.
This course will address the current adverse events report format and content for non-approved medicinal products (Drug Safety Update Reports – DSURs) and review a sample DSUR. We will also discuss the newly-required Periodic Benefit-Risk Evaluation Report (PBRER). Additionally, the instructor will highlight the different requirements of the US and the EU.
This webinar discusses how you can run a compliant, efficient AE reporting program. At the end of this 90-minute interactive session, you will be able to:
- Summarize how to build a compliant program while avoiding common pitfalls
- Explain the different U.S. and EU reporting requirements
- Identify critical parts of the adverse event reporting process – from laying out SOPs through report writing