Advanced Pharmacovigilance is a course that covers topics such as:
- 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
Advanced Pharmacovigilance brings together safety professionals who are working both in the Clinical and Post-Marketing Safety arena including QA for auditing.
Advanced Pharmacovigilance will be held on 21-23 September 2022.