ADVANCED
PHARMACOVIGILANCE

Conference Date: 22-24 Sep 2010
Conference Ref: A9-4010
Fee: £1640 + VAT
Venue: The Rembrandt Hotel, London

This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. The course will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company.

This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines.

Key Topics to be covered:

• Due Diligence
• Training for Drug Safety - Reporting Duties
• Audits and Expectations
• Compliance and Drug Safety
• Independent Data Monitoring Boards
• Product Safety Reviews – Purpose and Function
• Safety Reporting in Licensing Agreements
• Developing Company Core Safety Information – CIOMS III
• PSURs
• The EU Clinical Trial Directive
• Risk/Benefit Determinations
• CIOMS V
• Crisis Management

Click here to book your place on this important event.