With more countries laying strict pharmacovigilance laws for drug safety, the demand for skilled professionals in the field of pharmacovigilance is more than ever. This course focuses on understanding and applying Good Pharmacovigilance practices within current European regulations guidelines while shedding a comparison with FDA regulations to enable the participant to analyze different GVP documentation and develop advanced knowledge of the roles and responsibilities of various functionaries in pharmacovigilance departments.
This course provides a solution for all professionals that need to acquire pharmacovigilance knowledge, it can also serve as a refresher course for others who are already working in the field of drug safety and pharmacovigilance.
The course consists of online internet based 16 contact hours.
English is the teaching language of the course. The participants will be given opportunity to discuss materials with the instructor during specific weekly hours.Learning outcomes:
Upon completion of this course participants will:
- Understand the basics of Good Pharmacovigilance practices and be able to explain the current legal regulations and guidelines.
- Understand the main GVP requirements related to the pharmacovigilance and risk management systems.
- Analyze essential documents related to GVP and understand the essence, purpose and structure of important trial related files such as the pharmacovigilance system master file (PSMF), the periodic safety update report (PSUR) and study protocol.