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Advanced pharmacovigilance course to be held in London from Sept 25-27, 2017

London, United Kingdom
Monday, January 02, 2017, 09:00 Hrs  [IST]

Advanced pharmacovigilance course will be conducted by Management Forum in London from September 25-27, 2017. The 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 include 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.

The course will help participants expand global safety knowledge, enhance their team’s capabilities and compliance in both the regulations and your company’s expectations; build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection. They can participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection.

 

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