Harmonizing Literature Monitoring
Brought to you by DIA in cooperation with
Harmonizing Literature MonitoringThe 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?
- 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
Professionals who work in the area of:
- Clinical Safety and Pharmacovigilance
- Regulatory Affairs
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.