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

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/jhlkx2/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/jhlkx2/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: Pharmaceuticals

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: Pharmaceuticals