The purpose of this course is to give you

• Knowledge and expertise of the classification of adverse reactions
• Awareness of why having a knowledge of adverse drug reactions is central to pharmacovigilance
• Understanding of the monitoring and evaluation of safety in clinical trials
• Understanding of spontaneous reporting of ADRs and its strengths and weaknesses

This course will enable you to

• Understand what safety issues need to be monitored and the appropriate methods and tools to use

• Understand what safety data needs to be reported and when and how this should be done

• Gain knowledge of spontaneous reporting, its advantages and limitations, factors influencing reporting and the reasons for under reporting

• Understand the necessary content of such reports,their follow-up, assessment and uses