(0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Online

Harmonizing Literature Monitoring

Adis Pharmacovigilance is the expert solution for regulatory literature monitoring, from the industry-leading provider of drug safety and pharmacovigilance content. We work in partnership with you to design and deliver a tailored solution.

Overview

Brought to you by DIA in cooperation with

Adis Pharmacovigilance 

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?

This on demand webinar recording is approximately 1 hour long.

Featured topics

  • Setting the scene with ICH
  • Current guidelines relating to pharmacovigilance
  • Selection of literature sources
  • ‘A patient’ = identifiable patient? – A case study
  • Handling multiple patient/aggregated reports
  • Screening for Non-ICSR content
  • Recommendations for harmonization

Who should attend?

Professionals who work in the area of:

  • Pharmaceuticals
  • Biotechnology
  • One or more products on the market, or close to being marketed
    • Including innovators and manufacturers of generics, OTC products, and biosimilars
  • Job titles include:
    • Global Safety Lead
    • Regulatory Affairs Manager
    • Toxicologist
    • Risk Manager/Analyst
    • Epidemiologist
    • Pharmacovigilance Specialist/Manager
    • Drug Safety Manager
    • QPPV
    • EU-QPPV

Learning objectives

At the conclusion of this offering, participants should be able to:

  • 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.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.