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

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

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

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

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

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