Clinical Development of a Vaccine

 

Clinical Development of a Vaccine

Clinical Research Related Courses

You want to understand the activities and specific requirements (quality, safety, efficacy and trial performance) of a vaccine trial? This course gives you the answers on the differences with pharmaceutical trials, identifies the challenges and  let you understand the biological business.

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Full 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 focusses on all practical aspects of the performance of clinical trials with vaccines.

Who should attend?

Managers & scientists involved in clinical research with vaccines

Regulatory managers of biological medicinal products

Project Managers & Clinical Research Associates (CRAs) working with biological medicinal products

Professionals in these fields wishing to refresh their knowledge and skills

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