The course aims to give you an overview and to define the concepts necessary to built a risk management plan for medicinal product.

This course aims, based on the experience of a large international pharmaceutical company, to define the general principles necessary to build a process for developing Risk Management Plans for a medicinal product by the Industry.

This course aims that you :

• become familiar with automated health care databases
• understand ongoing initiatives using data from the available databases
• understand different methods of signal generation using data from automated health care databases,
• know signal detection in longitudinal databases European Union Adverse Drug Reaction as example.