Advanced Pharmacovigilance
March 22 - 24, 2010(Ended)The Rembrandt Hotel
London, United Kingdom
London, United Kingdom
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
Venue
Address
11 Thurloe Place,
London,
United Kingdom
London,
United Kingdom
Prices *
1625 Pound Sterling
Organization
Important
Please, check the conference website for possible changes, before you make any traveling
arrangements
* Prices are for evaluation only.
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