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Advanced Pharmacovigilance


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Who should attend?

This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena including QA for auditing. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines PROGRAMME - DAY ONE

Details

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

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Contact

Leigh White
info@management-forum.co.uk

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