ADVANCED PHARMACOVIGILANCE
A 3 Day Advanced Level Course

Conference Date: 03 - 05 Oct 2007
Conference Ref: A10-4007
Venue: The Rembrandt Hotel, London

This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. It will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company. The group interactive sessions will highlight everyday situations that are going to be requiring thought and application of the legislation in order to generate the necessary compliance that will satisfy regulatory inspections. As well as expanding your global safety knowledge, this course will enable you to enhance your teams capabilities and compliance in terms of both the regulations and your Companys expectations. This will provide you with an excellent platform to build and maintain a quality Pharmacovigilance Department/Organisation ready for any Pharmacovigilance Inspection.

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 Trials Directive
- Risk/Benefit Determinations
- CIOMS V
- Crisis Management within Drug Safety


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