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