Informace o publikaci
RIS databáze – regulační informace na jednom místě
| Autoři | |
|---|---|
| Rok publikování | 2021 |
| Druh | Projekty výzkumu a vývoje |
| Fakulta / Pracoviště MU | |
| Citace | |
| Popis | 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. |
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