Safety Reporting Considerations for Medical Affairs

Safety Reporting Considerations for Medical Affairs is organized by Drug Information Association (DIA).

• Release Date: November 27, 2017
• Reviewed and Updated: September 14, 2023
• Expiration Date: September 14, 2026

Course Description:
This module covers the role of Medical Affairs in safety reporting. It discusses some safety basics, including history and background, governing organizations, and safety targets. It covers important Medical Affairs safety activities such as monitoring and communicating safety. Finally, the module discusses other safety-related topics such as medical ethics and risk management.

Featured topics:

• Safety and medical affairs
• Post-market activities
• Guidance and reporting
• Safety reporting best practices and case study

Learning objectives
Upon completion of this module, learners should be able to:

• Identify the relationship between safety reporting and Medical Affairs
• List Medical Affairs activities for post-market safety reporting
• Identify global guidances that relate to post-market safety reporting
• Outline best practices for Medical Affairs with respect to safety reporting and identify lessons from a safety reporting case study