Do you want to understand the activities and specific requirements for the clinical development of a vaccine? This course gives you the answers on the differences with pharmaceutical trials, identifies the challenges and let you understand the biological business. This eLearning includes a practical workshop on assessing risk/benefit ratio from the point of view of the regulator and the manufacturer.
This course highlights the highly demanding activities and specific requirements of regulatory characteristics – the quality, safety, efficacy, and clinical trial performance in the development of vaccines. We have 3 exquisite trainers, all having vast experience in vaccine development.
The first part of the course describes the characteristics of a vaccine trial with specific examples and discusses the future of vaccine trials and devices including organisational aspects of vaccine trials.
The second part focuses on the specific nature and potential impact of biological medicinal products and various types of vaccines that may be developed. It also covers the requirements for a pharmaceutical company to successfully achieve the development, licensing and marketing of vaccines.
Finally, the last part will discuss the importance of the Risk/Benefit evaluation in developing vaccines and even have a case study.