Harmonizing Literature Monitoring 

On-Demand Webinar


This Solution Provider Webinar is brought to you by DIA in cooperation with Adis Pharmacovigilance

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In This Webinar...

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?
Learning Objectives:    
  • 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

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

Presenters:

  • Suzanne Berresford, BPharm, PGDipClinPharm, PGCertClinEd, Group Product Manager, Adis Pharmacovigilance  
  • Kaoru Tada, BSc, PhD, LLM, Product Manager, Adis Pharmacovigilance