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@misc{1807063, author = {Rychlíčková, Jitka and Deml, Jiří}, keywords = {Database; EATRIS; RIS; CZECRIN}, language = {eng}, title = {RIS databáze – regulační informace na jednom místě}, url = {https://www.muni.cz/en/research/projects/61348}, year = {2021} }
TY - JFULL ID - 1807063 AU - Rychlíčková, Jitka - Deml, Jiří PY - 2021 TI - RIS databáze – regulační informace na jednom místě KW - Database KW - EATRIS KW - RIS KW - CZECRIN UR - https://www.muni.cz/en/research/projects/61348 N2 - Regulatory Information System (RIS) is an existing database summarizing and describing regulatory information of specific products. The database covers a wide range of products – medicinal products including ATMP, blood derived medicinal products and other; medical devices, GMO, borderline products etc. There is a specific part dedicated to vaccines. Nevertheless, the nature of vaccines is diverse in terms of regulatory categories. Therefore, not only the part of vaccines specifically plays a role as a source of regulatory information. The database covers all life cycles of a specific product. In case of medicinal products (vaccines included) there are following cycles: preclinical trials, clinical trials, manufacturing, placing on the market, marketing and commercials, pricing and reimbursement and vigilance. In case of other than medicinal products, it covers the most important phases. ER -
RYCHLÍČKOVÁ, Jitka a Jiří DEML. \textit{RIS databáze – regulační informace na jednom místě}. 2021.
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