Non-interventional Studies (NIS) (1 day)

Firstly, this seminar focuses on basics in epidemiology in order to remind the attendees of terms like cohort study, case-control study, incidence, prevalence, etc. Thereafter, emphasis is given to the delineation of terms and abbreviations like PAS, PASS, PAES, AWB, NIS, Late Phase, Phase IIIb, Post Marketing Surveillance, etc. The legal framework for NIS will be discussed, covering the German AMG as well as recommendations issued by the competent authorities. The Pharmaceutical Package (Dir 2010/84/EC, Reg (EU) No 1235/2010) will also be touched. Furthermore, practical aspects regarding the preparation, the conduct and finally the statistical evaluation and report writing for a NIS will be covered in this course. What is possible? What will not work? NIS - a challenge which will be critically investigated.

Online-Price: 740 € (19% VAT will be added)

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