Advanced Pharmacovigilance Course (Mar, 2019)

Advanced Pharmacovigilance Course is organized by Management Forum (Mf) Ltd and will be held from Mar 25 - 27, 2019 at The Rembrandt Hotel, London, England, United Kingdom.

The target audience for this medical event is 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

Course Overview:
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.

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 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)

Benefits of attending:
• Expand your global safety knowledge
• Enhance your team’s capabilities and compliance with 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 inspection

Tickets:
Early Fee (Before Dec 21, 2018): €2602.80
Late Fee (After Dec 21, 2018): €3106.80
Multiple booking discount for 2nd or subsequent delegates: €2640.78

Early Fee (Before Dec 21, 2018): USD 2,416.00 (+ Vat)
Late Fee (After Dec 21, 2018): USD 2,884.00 (+ Vat)

Additional details will be posted as soon as they are available.