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Safety Reporting Considerations for Medical Affairs


Overview

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 overview
  • Postmarket 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:

  • Discuss the relationship between safety reporting and Medical Affairs, including history, governing organizations, safety targets and role overview
  • List and describe Medical Affairs activities for postmarket safety reporting
  • Identify global guidances that relate to postmarket safety reporting and discriminate between solicited versus unsolicited reports
  • Outline best practices for Medical Affairs with respect to safety reporting and identify lessons from a safety reporting case study

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