Advanced Pharmacovigilance

Topics

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

Who should Attend

Safety professionals who are working both in the Clinical and Post-Marketing Safety arena including QA for auditing.