DEML, Jiří, Edita PLEVOVÁ and Jitka RYCHLÍČKOVÁ. How to navigate the Regulatory maze. Preclinical vaccine development: Animal testing. How to bring the products to patients (How to prepare a dossier for MA). In European Vaccine Research and Development Infrastructure. 2021.
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Basic information
Original name How to navigate the Regulatory maze. Preclinical vaccine development: Animal testing. How to bring the products to patients (How to prepare a dossier for MA)
Authors DEML, Jiří (203 Czech Republic, guarantor, belonging to the institution), Edita PLEVOVÁ (203 Czech Republic, belonging to the institution) and Jitka RYCHLÍČKOVÁ (203 Czech Republic).
Edition European Vaccine Research and Development Infrastructure, 2021.
Other information
Original language English
Type of outcome Requested lectures
Field of Study 30230 Other clinical medicine subjects
Confidentiality degree is not subject to a state or trade secret
WWW URL URL
RIV identification code RIV/00216224:14110/21:00123799
Organization unit Faculty of Medicine
Keywords (in Czech) regulace; vakcína; preklinický výzkum; testování na zvířatech; registrace; povolení k uvedení na trh
Keywords in English regulatory; vaccines; preclinical research; animal testing; registrations; marketing authorisation
Tags MU, přednáška, RIV
Tags International impact
Changed by Changed by: Bc. Hana Vladíková, BBA, učo 244692. Changed: 18/1/2022 10:59.
Abstract
Training scientists in vaccine research and development is crucial in order to sustain Europe’s excellence in this field. The TRANSVAC2 Consortium has set up training modules at leading European centres (in collaboration with WP18 partners) that can be combined to create customised international courses on vaccine R&D. Two rounds of customised training courses are planned. Participants can select topics as needed in their field of vaccine development, and the timelines of the various modules will be harmonised in a way that allows a logical continuation from one topic to the other. Organized by EATRIS, this two-day interactive training workshop on vaccine development will introduce participants to planning a regulatory strategy for vaccines with emphasis on the early phases of development. Day 1 will focus on prophylactic vaccines while day 2 will focus on cancer vaccines. The workshop will be designed based on the current bottlenecks and upcoming innovative approaches while planning a regulatory strategy. The course is designed for professionals working on vaccine development who are in need of an introduction to the regulatory issues associated with the field.
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
PrintDisplayed: 26/4/2024 12:09