The course, a Thomson Reuters Cortellis Regulatory Online Learning module, examines pharmacovigilance and its purpose. The course covers terms and concepts as well as the origin of pharmacovigilance and its evolution from a reactive to a proactive approach. For each of the three International Conference on Harmonisation (ICH) regions, the course discusses in detail pharmacovigilance legal basics, regulatory requirements that pharmaceutical companies must adhere to, and the parties involved in medical product safety monitoring.
- Basics of pharmacovigilance
- Pharmacovigilance in the three ICH regions
Who Should Attend
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Define pharmacovigilance and identify related terminology
- Explore the origin of pharmacovigilance and its aims
- Recognise the role of the organisations involved in pharmacovigilance
- Outline pharmacovigilance framework in the European Union, United States and Japan
- Identify the parties involved in pharmacovigilance in the three regions
The course takes an average of 1.5 hours to complete.
Click here for minimum system requirements.