1. Adverse Event Reporting
A discussion for the IADSA Annual Meeting
March 2011

2. Adverse Event Reporting
Principles
Internal processes should be resolved before regulatory controls are initiated

3. Adverse Event Reporting
Principles
Internal processes should be resolved before regulatory controls are initiated
IADSA produced guidance to assist companies to resolve internal processes

4. Adverse Event Reporting
Principles
Internal processes should be resolved before regulatory controls are initiated
IADSA produced guidance to assist companies to resolve internal processes
…leading to the creation of national / international systems

5. Adverse Event Reporting
Processes
Receive
Assess (individual)
Respond
Analyse (series)

6. Adverse Event Reporting
Work structure
CRN UK led global expert working group
Gain full international understanding
Develop Guidance to companies
Test implementation in different countries with different sized companies
Eventually share good practice with international regulators