Clinical research course
Paediatric Clinical Development
Focus on the paediatric regulations and their practical implementations.
Dates and booking
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Who it’s for
Is this course for you?
- Medical Directors and others responsible for developing paediatric research portfolios
- Regulatory staff involved in paediatric development
- Monitors and auditors responsible for overseeing paediatric research
- Paediatric research investigators, research coordinators and nurses
- Members of ethics committees reviewing paediatric research proposals
What you’ll learn
About this course.
Course Description
The 2-day course provides an overview of medical, regulatory, ethical, organisational and practical aspects of designing and performing clinical trials with children. It is designed to assist those in industry and academia produce scientifically and ethically sound research with data and results that contribute to improved paediatric medical practice while meeting the needs of regulatory authorities. Also, obligations and incentives stemming from the paediatric regulation will be discussed from a legal and practical point of view, including the background of the paediatric regulatory landscape. Lectures provide sound knowledge regarding the development of paediatric research programmes, while interactive workshops & cases will assist participants to apply this knowledge to the needs of their own institutions and organisations. We have added a second day to this programme, to include more practical sessions on the importance of paediatric research, PIP development and a brand-new session sharing best practices from an Industry and Regulators point of view.
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 organized and which meet the practical needs of patients, families, researchers and sponsor organizations
- Explain the need and content of a paediatric investigational plan (PIP)
- Share best practices from an industry as well as regulators point of view
Programme highlights
- Background and importance of clinical trials
- Obligations to perform paediatric clinical trials
- Incentives to perform paediatric clinical trials
- Paediatric Clinical Research in practice
- Practical implementation of the paediatric regulations
- Development of a paediatric investigational plan (PIP)
- Sharing best practices from an industry and regulators point of view
Hands-on workshops
Sharing best practices in paediatric clinical development
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Ethical & Participants Safety Considerations6
- Scientific Concepts & Research Design4
- Investigational Product Development and Regulation4
- Study and Site Management2
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.