Advanced Pharmacovigilance
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This three-day course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
- Audits and expectations – risk-based inspections
- Compliance and drug safety
- Overview of the PSMF in the EU
- Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
- Safety reporting in licensing agreements
- Developing company core safety information (CCSI) – CIOMS III
- PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
- Implications for safety reporting in global clinical trials
- Risk-benefit determinations
- Risk management plans (RMPs)
By attending this event, you will:
- Expand your global safety knowledge
- Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
- Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
- Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections
Upcoming start dates
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Reviews by course attendees
Average rating 4.5
I was hoping to broadening my PV knowledge in the human area and to be able to compare with my knowledge in veterinary PV. I thought the subjects were perfect and lever also goo...
Fantastic - I would recommend this course to all in this field of work.
He (Graeme Ladds) is a very experienced professional and his practical examples of inspections' findings in companies were really useful to understand what the main faults are.