Advanced Pharmacovigilance Course - London, U.K. - 25th-27th September 2017 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Advanced Pharmacovigilance (London, U.K. - 25th-27th September 2017)" conference to their offering.

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 http://www.researchandmarkets.com/research/sksbc9/advanced

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Drug Discovery

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Drug Discovery