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. We have updated the programme this year, to include a practical workshop on assessing risk/benefit ratio from the point of view of the regulator and the manufacturer.
This 2-days 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. We do have 3 exquisite trainers, all having vast experience in vaccine development.
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. Finally, the last part (on the second day) will include a workshop where participants will assess risk/benefit ratio from the point of view of the regulators and manufacturer.