Clinical vaccine development and biomanufacturing
M1
Course Goals
1. To give an overview of . vaccine biomanufacturing including considerations for taking pre-clinical vaccine candidates into GMP manufacture, the principles of GMP (good manufacturing practice), and an overview of small to large scale manufacture.
2. To provide an overview of vaccine clinical development including examples from experimental and licensed vaccines; to impart the importance of clinical trial design, immunomonitoring, statistical considerations and ethical considerations.
Course content
A list of the course contents is given on the website, link below. It includes a visit to a small-scale biomanufacturing facility. For more in-depth information on course content and structure check
Learning Outcomes
A. To gain an understanding of the vaccine development process, including GMP manufacture and testing vaccine safety and efficacy in clinical trials.
B. To be able to apply the understanding to vaccines being designed, manufactured and developed by the participant
Who should apply
Anyone working in vaccinology, or interested in learning about the vaccine clinical development process, including those from academia, industry, or regulatory bodies.
Minimal requirements
None, but ideally a background in biological science and/or first degree in related subject.
Accommodation
Accommodation will be provided. Travel Costs are not included.
Comments
NA