Three Day Course: Advanced Pharmacovigilance (London, United Kingdom - March 7th-9th, 2018)

This course will be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing

Course overview

This course is designed for those with at least two 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

Why you 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 including QA for auditing. 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

Agenda:

Programme - Day one

09.00 Registration and Coffee

09.30 Start of meeting

Due Diligence

Training for Drug Safety Reporting Duties

Audits and Expectations

Compliance and Drug Safety

The PV Master File and the DDPS

17.00 Close of day one

Programme - Day Two

09.00 Start of day two

Product Safety Reviews - Purpose & Function

INTERACTIVE EXERCISE: Designing the Requirements for a Safety Review Group

Safety Reporting in Licensing Agreements

Developing Company Core Safety Information - CIOMS III

INTERACTIVE EXERCISE: Deciding whether New Safety Data presented from a Clinical Trial should be put into Core Safety Information

PSURs and the New Revisions in ICH E2C

17.00 Close of day two

Programme - Day Three

09.00 Start of day three

The EU Clinical Trials Directive

Risk/Benefit Determinations

INTERACTIVE EXERCISE: Reviewing the Safety of a Product

Risk Management Plans (including new EU requirements 2012)

Crisis Management within Drug Safety

Interactive Exercise: Deciding how to Handle a Major Crisis within the Company

16.30 Close of day three

09.00 Start of day three

The EU Clinical Trials Directive

Risk/Benefit Determinations

INTERACTIVE EXERCISE: Reviewing the Safety of a Product

Risk Management Plans (including new EU requirements 2012)

Crisis Management within Drug Safety

Interactive Exercise: Deciding how to Handle a Major Crisis within the Company

16.30 Close of day three

For more information about this conference visit https://www.researchandmarkets.com/research/3sw9wj/three_day_course?w=5

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Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com  

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