Clinical Development Of A Vaccine

This course describes the differences between vaccine trials and pharmaceutical trials, identifies the challenges, and lets you understand the biological business. This 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 module of the course describes the characteristics of a vaccine trial in general and specific examples. This module draws attention to the particularities of a vaccine trial compared to a drug trial. Moreover, the possible issues and challenges from a vaccine trial are addressed. Key aspects are: types of participants, organisation, recruitment and the correct administration technique. Afterwards, the theory will be illustrated with examples of recently conducted vaccine trials and accompanied by a glance at the future of vaccine trials and devices in vaccine trials. The second module of this training will give an overview of the specific regulatory nature and potential impact of biological medicinal products and the various types of vaccines that may be developed. The third module gives the basic elements and illustrates the importance of the risk/benefit ratio of a vaccine from different points of view: the regulator and the manufacturer.

Programme highlights include:

• The characteristics of a vaccine trial in general and with specific examples – bridging with the specific nature of vaccines
• Discussion on the future of vaccine trials and devices in vaccine trials, including organizational aspects of vaccine trials
• Illustrations with recently performed vaccine trials
• The value of vaccines for the individual and for the society”: Overview of the specific nature and potential impact of biological medicinal products and the various types of vaccines that may be developed
• Requirements for a pharmaceutical company to successfully achieve the development, licensing and marketing of vaccines
• Risk/benefit ratio assessment

Further details following soon.