INTRODUCTION
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. 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 team s capabilities and compliance in terms of both the regulations and your Company`s expectations. This will provide you with an excellent platform to build and maintain a quality Pharmacovigilance Department/ Organisation ready for any Pharmacovigilance Inspection.
WHO SHOULD ATTEND
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
- Product Safety Reviews Purpose and Function
- Safety Reporting in Licensing Agreements
- Developing Company Core Safety Information CIOMS III
- PSURs Timing, Content and the DSUR
- The EU Clinical Trial Directive
- Risk/Benefit Determinations
- Crisis Management within Drug Safety
With:
Graeme Ladds Director, PharSafer
Comments from previous delegates include:
Extremely interesting topics discussed, clear presentations, well delivered
Very informative and really helpful
Perfect course, clearly explained with lots of examples
