Gain a recognized and traceable certificate after completing the course :
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Pharmacovigilance contributes to the protection of patients and public health in an essential way. It is highly mandatory for life sciences manufacturers to follow GVP with programs in place that focus on risk assessment and management. This course is based on the official GVP guidelines and is a complete training program for all individuals that need a refresher. You will learn about identification and assessment of safety signals for good reporting practice, as well as the features of a good case report. At the end you’ll be able to develop a pharmacovigilance plan.
This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Identifying Safety Signals
Lesson 2: Signal Investigation through Observational Studies
Lesson 3: Interpreting Safety Signals
Lesson 4: How to Develop a Pharmacovigilance Plan