Detailed Information on Publication Record
2021
RIS databáze – regulační informace na jednom místě
RYCHLÍČKOVÁ, Jitka and Jiří DEMLBasic 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
Language
English
Type of outcome
Projekty výzkumu a vývoje
Field of Study
30230 Other clinical medicine subjects
Country of publisher
Czech Republic
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
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
Změněno: 18/7/2022 11:08, Bc. Hana Vladíková, BBA
Abstract
V originále
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 project |
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