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)

p 2021

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)

DEML, Jiří, Edita PLEVOVÁ a Jitka RYCHLÍČKOVÁ

Základní údaje

Originální název

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)

Autoři

DEML, Jiří (203 Česká republika, garant, domácí), Edita PLEVOVÁ (203 Česká republika, domácí) a Jitka RYCHLÍČKOVÁ (203 Česká republika)

Vydání

European Vaccine Research and Development Infrastructure, 2021

Další údaje

Jazyk

angličtina

Typ výsledku

Vyžádané přednášky

Obor

30230 Other clinical medicine subjects

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL URL

Kód RIV

RIV/00216224:14110/21:00123799

Organizační jednotka

Lékařská fakulta

Klíčová slova česky

regulace; vakcína; preklinický výzkum; testování na zvířatech; registrace; povolení k uvedení na trh

Klíčová slova anglicky

regulatory; vaccines; preclinical research; animal testing; registrations; marketing authorisation

Štítky

MU, přednáška, RIV

Příznaky

Mezinárodní význam

Změněno: 18. 1. 2022 10:59, Bc. Hana Vladíková, BBA

Anotace

V originále

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.

Návaznosti

LM2018128, projekt VaV

Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Akronym: CZECRIN)

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, Český národní uzel Evropské sítě infrastruktur klinického výzkumu (CZECRIN)

Citovat

DEML, Jiří, Edita PLEVOVÁ a 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.

@misc{1823238,
   author = {Deml, Jiří and Plevová, Edita and Rychlíčková, Jitka},
   booktitle = {European Vaccine Research and Development Infrastructure},
   keywords = {regulatory; vaccines; preclinical research; animal testing; registrations; marketing authorisation},
   language = {eng},
   note = {RAPHE},
   title = {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)},
   url = {https://eatris.eu/events/transvac2-workshop-on-regulatory-aspects-of-vaccine-development/},
   year = {2021}
}

TY  - SLIDE
ID  - 1823238
AU  - Deml, Jiří - Plevová, Edita - Rychlíčková, Jitka
PY  - 2021
TI  - 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)
N1  - RAPHE
KW  - regulatory
KW  - vaccines
KW  - preclinical research
KW  - animal testing
KW  - registrations
KW  - marketing authorisation
UR  - https://eatris.eu/events/transvac2-workshop-on-regulatory-aspects-of-vaccine-development/
N2  - 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.
ER  -

DEML, Jiří, Edita PLEVOVÁ a 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 \textit{European Vaccine Research and Development Infrastructure}. 2021.

Podrobný výpis o publikaci