RYCHLÍČKOVÁ, Jitka and Jiří DEML. RIS databáze – regulační informace na jednom místě (Regulatory Information System). 2021.
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Basic information
Original name RIS databáze – regulační informace na jednom místě
Name in Czech RIS databáze – regulační informace na jednom místě
Authors RYCHLÍČKOVÁ, Jitka (203 Czech Republic, guarantor, belonging to the institution) and Jiří DEML (203 Czech Republic, belonging to the institution).
Edition 2021.
Other information
Original language English
Type of outcome Research and development projects
Field of Study 30230 Other clinical medicine subjects
Country of publisher Czech Republic
Confidentiality degree is not subject to a state or trade secret
WWW URL
RIV identification code RIV/00216224:14110/21:00124701
Organization unit Faculty of Medicine
Keywords (in Czech) Databáze; EATRIS; RIS; CZECRIN
Keywords in English Database; EATRIS; RIS; CZECRIN
Tags EATRIS, ECRIN, MU, operator, RIV
Changed by Changed by: Bc. Hana Vladíková, BBA, učo 244692. Changed: 18/7/2022 11:08.
Abstract
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.
Links
LM2018128, research and development projectName: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)
Investor: Ministry of Education, Youth and Sports of the CR
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