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Safety Reporting Considerations for Medical Affairs

Review how Medical Affairs plays an important role in safety reporting.


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.

This module takes an average of 1.5 hours to complete.

This eLearning module can be purchased individually or as part of the Medical Affairs eLearning Program (11 modules).

Featured topics

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

Who should attend?

  • This program is designed for professionals involved in:

    • Medical Director
    • Medical Manager/Medical Adviser
    • Medical Communications/Medical Information
    • Clinical Operations - those who have been assigned the task of supporting Medical Affairs studies

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
  • Recognize the 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

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