Clinical Development of a Vaccine – What Makes Vaccines Different?
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| Clinical Development of a Vaccine – What Makes Vaccines Different? | eLearning | USD 840 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Do 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. This eLearning includes a practical workshop on assessing risk/benefit ratio from the point of view of the regulator and the manufacturer.
Course schedule
- Course duration: 5h
- Complete the course at anytime, anywhere!
This course highlights the highly demanding activities and specific requirements of regulatory characteristics – the quality, safety, efficacy, and clinical trial performance in the development of vaccines. We have 3 exquisite trainers, all having vast experience in vaccine development.
The first part of the course describes the characteristics of a vaccine trial with specific examples and discusses the future of vaccine trials and devices including organisational aspects of vaccine trials.
The second part focuses on the specific nature and potential impact of biological medicinal products and various types of vaccines that may be developed. It also covers the requirements for a pharmaceutical company to successfully achieve the development, licensing and marketing of vaccines.
Finally, the last part will discuss the importance of the Risk/Benefit evaluation in developing vaccines and even have a case study.
Programme highlight
- The value of vaccines for the individual and for the society”: Overview of the specific nature and potential impact of biological medicinal products and the various types of vaccines that may be developed
- Requirements for a pharmaceutical company to successfully achieve the development, licensing, and marketing of vaccines
- The characteristics of a vaccine trial in general and with specific examples – bridging with the specific nature of vaccines
- Discussion on the future of vaccine trials and devices in vaccine trials, including organizational aspects of vaccine trials
- Illustrations with recently performed vaccine trials
- Risk/benefit ratio assessment
Learning objectives
- Explain the particularities of a vaccine trial compared to a drug trial and the types of participants, and organization of recruitment, in a vaccine trial
- Describe the biologics business
- Identify challenges and possible issues
- Illustrate the theory with examples of recently conducted vaccine trials
Who should attend
- Managers & scientists involved in clinical research with vaccines
- Regulatory managers of biological medicinal products
- Project Managers & Clinical Research Associates (CRAs) working with biological medicinal products
- Professionals in these fields wishing to refresh their knowledge and skills
Competencies
- Scientific Concepts & Research Design (5)
- Ethical & Participants Safety Considerations (4)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (4)
- Study and Site Management (2)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
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