Found 5 relevant results in 2.78s where lecturer="Katharina Hartmann"
Introduction of basic concepts and methods in Public Health, epidemiology, and Evidence Based Medicine. An overview on concepts and principles of clinical trials on efficacy of drugs
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Module 5: Regulatory Affairs
Modul 5: Regulatory Affairs
The module Regulatory Affairs covers different areas of pharmaceutical sciences and legislation in Switzerland, the EU and, where appropriate, in other markets such as the US one. It provides knowledge about the marketing authorisation processes and the contents of regulatory documentation. It offers insight into regulatory strategies and reimbursement processes.
Module 8: Pharmacovigilance
Modul 8: Pharmacovigilance
The module Pharmacovigilance covers the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. It provides knowledge on the basis of adverse events, regulations and guidelines, handling safety issues, labeling and risk management systems and processes during the pre- and postmarketing phase of medicinal products.
Introduction to the principles, methods and applications of pharmacoepidemiology and drug safety. Drug safety in the pharmaceutical industry and regulatory authorities, but also for hospital and office pharmacists. Another focus is the evaluation and interpretation of pharmacoepidemiological drug safety studies in the medical literature and the evaluation of benefits vs. risks.