This course aims to introduce the topic on risk management plans and give some basic information to better understand the key aspects.

This course aims to present objectives and activities to be proposed in the two sections of the Risk Management Plan:

• the pharmacovigilance plan
• the risk minimisation plan

The objectives of this course are to:

• 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