Moving your Vaccine Product from the Lab to Humans
Why Should You Attend:
Most of the scientists working on the pre-clinical stages of vaccine development do not fully understand what is the process that the vaccine candidate must follow in order to be approved for human consumption. Furthermore, it is very important to acquire knowledge of the necessary pre-requisites that the vaccine candidate must fulfill to be considered successful and ready to go into human testing. Timely knowledge about these requirements and processes will help avoid costly mistakes and delays and will provide a sound basis to develop a path and a timeline to follow thus securing the success of your vaccine candidate.
This webinar training will provide a comprehensive understanding of the process for bringing your vaccine candidate from the laboratory to humans. You will learn what are the necessary pre-conditions that your vaccine candidate must fulfill to proceed from the pre-clinical to clinical testing. Step-by-step procedures will be outlined that need to be followed in order to transition to testing in humans. This will include the documents required by FDA to obtain an approval to conduct a clinical trial in humans. The phases of clinical testing in humans and requirements to progress to the next stage will also be outlined. Common mistakes that could cause unnecessary and costly delays will be discussed.
Areas Covered in this Webinar:
The webinar will include the following critical information you will need:
- Pre-clinical development
- Pre-clinical testing
- Relevance of immunogenicity and safety in animal models
- Quality control and batch release
- Phases of clinical development
- Clinical study designs
- Regulatory requirement for clinical testing
- Testing vaccines in the developing world
