This is basic training, valuable especially for new pharmacovigilance employees.
During the course I will discuss basic legal requirements regarding pharmacovigilance. You will learn about the legal act hierarchy in the European Union. Where to find those acts, the data sources. Then you will learn about roles of different parties in pharmacovigilance – WHO, CIOMS, EMA, MAH, national competent authority. I will also give a short introduction about guidelines on good pharmacovigilance practices and about pharmacovigilance tasks performed by MAH.
The course also includes some practice and a course test. The trainee will get competence to define where to find legal and practical knowledge and will receive a certificate after passing the course test.
