Clinical Development of a Vaccine
European Centre for Clinical Research Training (ECCRT)
Archiv
04.06.2014 Brussels, Belgien
Kursinhalte
This 1-day course highlights the highly demanding activities and specific requirements, regarding the regulatory characteristics - quality, safety, efficacy - as well as clinical trial performance in the development of vaccines.
The first part of the course describes the regulatory aspects of the development and marketing authorisation of biological medicinal products. The second part will focus on all practical aspects of the performance of clinical trials with vaccines.
This 1-day course highlights the highly demanding activities and specific requirements, regarding the regulatory characteristics - quality, safety, efficacy - as well as clinical trial performance in the development of vaccines.
The first part of the course describes the regulatory aspects of the development and marketing authorisation of biological medicinal products. The second part will focus on all practical aspects of the performance of clinical trials with vaccines.
Lernziele, Trainingsziele
Understand the biological business. Identify challenges and possible issues. Illustrate the theory with some examples of recently conducted vaccine trials.
Understand the biological business. Identify challenges and possible issues. Illustrate the theory with some examples of recently conducted vaccine trials.
Zielpublikum
Managers & scientists involved in clinical research with vaccines , Regulatory managers, biological medicinal products , Project managers & CRAs, biological medicinal products, Professionals in these matters wishing to refresh their skills
Managers & scientists involved in clinical research with vaccines , Regulatory managers, biological medicinal products , Project managers & CRAs, biological medicinal products, Professionals in these matters wishing to refresh their skills
Typische Postgraduate Berufsfelder und Berufschancen
CRA, Clinical Research Associate, PM, Project Manager
CRA, Clinical Research Associate, PM, Project Manager
Zertifizierung
ISO9001:2008/ Q-for
ISO9001:2008/ Q-for
Lokaler Veranstalter
ECCRT
ECCRT
Anfragen und Anmeldung:
Frau Sunita Kelecom
Klinische Forschung
Veranstalter Kontakt
Marcel Broodthaers plein 8b5
1060 Brussels
Belgien
Marcel Broodthaers plein 8b5
1060 Brussels
Belgien
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