Clinical Development of Vaccines

Tijdsduur
Startdatum en plaats
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Startdata en plaatsen

Brussels
25 nov. 2019 tot 26 nov. 2019

Beschrijving

Clinical Development of Vaccines

Course Description

This one day course highlights the highly demanding activities and specific requirements of regulatory characteristics – the quality, safety, efficacy and also clinical trial performance in the development of vaccines.
The first part of the course describes the regulatory aspects of the development and marketing authorization of biological medicinal products. The second part will focus on all practical aspects of the performance of clinical trials with vaccines.

Learning objectives

• To explain the particularities of a vaccine trial compared to a drug trial and the types of participants, and organization of recruitment, in a vaccine trial
•…

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Veelgestelde vragen

Heb je een vraag? Onze adviseurs helpen je graag. Bel ons op 085 7440830 of e-mail naar info@springest.nl.

Clinical Development of Vaccines

Course Description

This one day course highlights the highly demanding activities and specific requirements of regulatory characteristics – the quality, safety, efficacy and also clinical trial performance in the development of vaccines.
The first part of the course describes the regulatory aspects of the development and marketing authorization of biological medicinal products. The second part will focus on all practical aspects of the performance of clinical trials with vaccines.

Learning objectives

• To explain the particularities of a vaccine trial compared to a drug trial and the types of participants, and organization of recruitment, in a vaccine trial
• To understand the biologics business
• To identify challenges and possible issues
• To illustrate the theory with examples of recently conducted vaccine trials

Programme highlights

• Overview of the specific nature of biological medicinal products and the various types of vaccines
that may be developed
• Requirements a pharmaceutical company has to face to achieve the development and marketing of vaccines, including:

• Parameters to be studied (Quality, Safety, Efficacy)
• Clinical trials authorization specificity
• Regulatory aspects of marketing authorization for biologics
• Registration Dossier contents

• Characteristics of a vaccine trial in general and with specific examples
• Discussion on the future of vaccine trials
• Illustrations with recently performed trials

Who should attend

Managers & scientists involved in clinical research with vaccines, regulatory managers of biological medicinal products, project managers & CRAs working with biological medicinal products, professionals in these fields wishing to refresh their knowledge
and skills

*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.

Trainers: Mr. Hugues Bogaerts, PhD, Prof. Pierre Van Damme, MD, PhD

Language: English

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Deel je ervaring

Heb je ervaring met deze cursus? Deel je ervaring en help anderen kiezen. Als dank voor de moeite doneert Springest € 1,- aan Stichting Edukans.

Heb je een vraag? Onze adviseurs helpen je graag. Bel ons op 085 7440830 of e-mail naar info@springest.nl.

Vraag nu gratis en vrijblijvend informatie aan:

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