How to prepare your vaccine candidate for the clinic
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About this course
Reasons to attend
This course will improve your understanding of the pitfalls of pre-clinical vaccine development.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course Description
Before vaccines make it to the clinic, called pre-clinical development, it is often a lengthy, challenging and cost-intensive process. Very often, hard choices must be made between never-ending original ideas to make the product “better”, feasibility, available investments, timelines not to forget production requirements, anticipation regulatory requirements and market needs.The better this pre-clinical phase is planned, the better the chances all data generated during this phase can be used in the final dossier and do not have to be redone, sometimes from scratch, for quality and regulatory requirements.The training "How to prepare your vaccine candidate for the clinic" will go through this process with examples experienced by the trainer. He will use the COVID vaccine developments and other vaccine developments as examples and particularly emphasise critical stages for going no-go decisions.Programme highlight
- From a bright research idea to product development
- Basic data to be generated
- Challenges for innovative processes, platform technologies for vaccine production
- Get regulators involved early in the process
Learning objectives
- Identify the process from bright research idea to product ready for clinical development
- Define which data are needed before moving to the clinic with a new vaccine
- Identify challenges during the development process of new vaccines using new processes/platform technologies
Who should attend
Clinical Research Professionals, Regulatory Affairs Professionals, Project Managers, R&D Managers, and anyone involved in the development programs of vaccines, translational research professionals in the vaccine field.
Background needed: this course is designated for the same with 5 years' experience. Basic knowledge about virology, bacteriology and immune responses is recommended. The course particularly addresses those who want to translate a research idea into a vaccine that is expected to make it to the market.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (5)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
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