- understand what constitutes post-marketing surveillance, including the definition and scope of post-marketing surveillance, risk management plans, post authorisation safety studies, types of studies, post-marketing spontaneous reporting, signal detection, tools for signal detection, interpretation of findings, actions following a confirmed signal, SPC update, crisis management, execution of recalls and product life cycle management

- analyse and post authorisation safety studies and enterpret signals and findings, etc.

- use and prepare risk management plans, update SPCs and execute recalls and manage life cycle management in a highly dynamic and constantly changing environment

 

·         Overview of post-marketing surveillance

·         Risk management plans

·         PASS

·         Types of studies

·         Post-marketing spontaneous reporting

·         Signal detection

·         Databases for spontaneous reporting

·         Tools for signal detection

·         Current practice of agencies in signal detection

·         Interpretation of findings and documentation hereof

·         Actions following a confirmed signal

·         SPC update and harmonisation

·         Reporting of signals 

·         Crisis managment/product recall

·         Counterfeit

·         Product life cycle management

Other participants will be considered on a case-by-case basis.

Approximately 25 participants will be admitted to each module.

For some modules, prior attendance at specific modules, or equal experience, is recommended. This appears from the description of the individual modules.