PharmiWeb.com - Global Pharma News & Resources
25-Mar-2019 - 27-Mar-2019

Advanced Pharmacovigilance

  • Location:
    • Venue to be confirmed

Course overview

This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.

KEY TOPICS TO BE COVERED

  • Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
  • The DDPS retirement and the New PV Master file in the EU
  • Compliance and Drug Safety
  • Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
  • Developing Company Core System Information CIOMS III
  • Safety Reporting in Licensing Agreements
  • PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
  • Implications for Safety Reporting in Global Clinical Trials
  • Risk/Benefit Determinations
  • Risk Management Plans