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 and Jitka RYCHLÍČKOVÁ

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

Language

English

Type of outcome

Vyžádané přednášky

Field of Study

30230 Other clinical medicine subjects

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

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.

Links

LM2018128, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

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.

@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 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 \textit{European Vaccine Research and Development Infrastructure}. 2021.

Detailed Information on Publication Record