Overview

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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?

Featured topics

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

Who should attend?

Professionals who work in the area of:

Clinical Safety and Pharmacovigilance
Outsourcing
Regulatory Affairs

Learning objectives

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.