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. We have updated the programme this year, to include a practical workshop on assessing risk/benefit ratio from the point of view of the regulator and the manufacturer.
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. We do have 3 exquisite trainers, 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 focusses 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 risk/benefit ratio from the point of view of the regulators and manufacturer.
25-26 November 2019 in Brussels, Belgium
Day 1: 08h30 – 17h30 / Day 2: 08h30 – 12h00
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
- 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
- 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
This course covers competencies that are part of the ECCRT Competency Framework
- 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)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.