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Harmonizing Literature Monitoring


概要

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Harmonizing Literature Monitoring

The regulatory guidelines for literature monitoring across the globe are diverse and can be open to interpretation. We will explore certain aspects framed by this situation:
  • What literature sources are selected and what is the basis for this?
  • What is the approach to screening for safety content other than ICSRs?
  • How can best practices be better shared within the industry?

特集トピック

  • The diversity in application and interpretation of literature monitoring guidelines
  • Setting the scene – ICH and guidelines relating to pharmacovigilance
  • Selection of sources for literature screening
  • ‘A patient’ – A case study
  • Approach to reports of multiple patients
  • Screening literature for other safety content
  • Recommendations for harmonisation

参加対象

Professionals who work in the area of:

  • Clinical Safety and Pharmacovigilance
  • Outsourcing
  • Regulatory Affairs

学習目的

Upon completion of the webinar, participants will have a better understanding of:

  • Define the key differences in major regulatory guidelines relating to literature screening activities
  • Identify some of the key differences in interpretation and application of such guidelines
  • Apply approaches to handle the diversity


Continuing Education Credits are not available for this event.


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