Three Day Advanced Pharmacovigilance Course - London, UK - September 28-30, 2016 -- Research and Markets

Apr 08, 2016, 07:10 ET from Research and Markets

DUBLIN, April 8, 2016 /PRNewswire/ --

Research and Markets has announced the addition of the "Advanced Pharmacovigilance (London, UK - September 28-30, 2016)" conference to their offering.

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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 Covered:

- 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

Why you should attend:

- 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 inspection

For more information visit

Media Contact:
Research and Markets
Laura Wood, Senior Manager

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SOURCE Research and Markets