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)

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DEML Jiří PLEVOVÁ Edita RYCHLÍČKOVÁ Jitka

Rok publikování 2021
Druh Vyžádané přednášky
Fakulta / Pracoviště MU

Lékařská fakulta

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Popis 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.
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