What is the impact of the vaccines in our society? What are the requirements for the clinical development of a vaccine?
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. Training by 3 exquisite speakers (Prof. Pierre Van Damme | Prof. Pieter Neels | Dr. Hugues Bogaerts), 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 focuses 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 the risk/benefit ratio from the point of view of the regulators and manufacturer.
During these 6 webinar sessions the highly demanding activities and specific requirements of regulatory characteristics will be featured – the quality, safety, efficacy, and clinical trial performance in the development of vaccines.
Quote: “The course was very interactive, and we had the possibility to really discuss the topics with the speakers and bring our own examples.” – Patricia Martin Killias from LimmaTech Biologics.
Reasons to attend
You want to understand the activities and specific requirements for the clinical development of a vaccine? This course gives you the answers to the differences with pharmaceutical trials, identifies the challenges, and lets you understand the biological business. The update of the programme this year includes a practical workshop on assessing risk/benefit ratio from the point of view of the regulator and the manufacturer.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Find the full course schedule here.
2-Day Face-to-face: 09h00 to 17h00
Webinars: 6 sessions