Advanced Pharmacovigilance Course: London UK - 21st, 22nd, 23rd of September 2015

Jul 09, 2015, 06:22 ET from Research and Markets

DUBLIN, July 02, 2015 /PRNewswire/ --

Research and Markets(http://www.researchandmarkets.com/research/mp46fs/advanced) has announced the addition of the "Advanced Pharmacovigilance Course" conference to their offering.

This course is designed for those with at least 2 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:


- Due Diligence
- 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 Safety 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
- Crisis Management within Drug Safety

Benefits of Attending:

- 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

For more information visit http://www.researchandmarkets.com/research/mp46fs/advanced

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

SOURCE Research and Markets



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