Introduction to Paediatric Clinical Development
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About this course
Reasons to attend
This is an introductory course to understand the importance of doing clinical research in paediatrics, know the process in order to conduct a good clinical trial in paediatry, and the legislation in place and the impact on clinical development and regulatory obligations.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Course time: Webinar of 2h
Course Long Description
This course is intended to help you understand the evolution of the last 20 plus years of paediatric clinical development starting from a low regulated experimental field to a more regulated field with better defined requirements. This course is a 2-hour training to understand the basics around paediatric development focusing on the following aspects:- Why is it important to do clinical research in children?
- Know the process in order to conduct a good clinical trial in paediatry
- Understand where we are coming from and what legislation is now in place
Programme highlight
- Medical Importance of paediatric clinical research
- Impact of paediatric Legislation on Study Design & Drug Development
- Development of a paediatric Investigation Plan
Learning objectives
- Identify cases in which paediatric research is needed
- Design paediatric research protocols that meet the needs of children as well as research institutions
- Identify the most important regulatory and ethical considerations in paediatric research design
- Establish well designed paediatric research programmes that are appropriately organised, and which meet the practical needs of patients, families, researchers, and sponsor organisations
- Explain the need and content of a paediatric investigational plan (PIP)
- Share best practices from an industry as well as regulators point of view
Who should attend
Clinical research staff and regulatory staff that wish to understand the context and obligations of paediatric development.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (5)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (3)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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