69.00€
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.
Pharmacist. Graduated at Warsaw Medical University. Ph.D. in 2010.
Since 1996 dedicated to the regulatory area in Poland. At first as post-autorisation variations’ specialist, later as clinical trials and pharmacovigilance specialist at National Drug Institute.
Involved in Pharmacovigilance legislation implementation in Poland between 2010-2013.
Lecturer in different training courses in Poland and during local and international conferences in regulatory and pharmacovigilance area.
Holds certificate in EVDAS (EudraVigilance Data Analysis System) and EV (Eudravigilance) ADR Reporting.
Loves music, trying to learn being a drummer (since 2016). Knitting especially during long winter evenings. Taking care of dear Son and cat.
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