This interactive and engaging course was developed by industry experts with a wealth of clinical trial and QA experience. This course provides the user with a firm understanding of pharmacovigilance and its relationship with drug safety. It explains the various pharmacovigilance regulations and requirements globally. It also examines how and why pharmacovigilance came into being and the basis of adverse drug reactions, including the identification, categorisation and reporting of safety events.
This course is suitable for anyone carrying out or involved in pharmacovigilance, drug safety, regulatory or quality compliance. It will provide individuals with certification in Pharmacovigilance that is widely accepted by sponsors and CROs. It was created by our subject matter expert, who has worked in clinical research for over 30 years and has delivered clinical research training all around the world.
- Understand what pharmacovigilance is and why it is necessary
- Examine the history of pharmacovigilance and the reasons for its implementation
- Understand global pharmacovigilance regulations, legislation and guidelines
- Learn how to identify, define and categorise safety events
- Understand how safety events are reported, including reporting formats and frequency of reports
- Examine the common abbreviations and definitions used in safety event reporting
- Identify the differences between safety event reporting in clinical vs post-marketing settings.