This training focuses on the paediatric regulations and their practical implementations. If you want to know more about the ins and outs of Paediatric Investigation Plans (PIP) and how to write them; this course is a must! We have revised the programme to now also include a 'sharing best practice session', with input from seasoned pharma industry experts.
This two-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 backgroundof the paediatric regulatory.
Lectures provide sound knowledge regarding the development of paediatric research programmes, while interactive workshops 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 importance of paediatric research, PIP development and a brand new session sharing best practices from an Industry and Regulators point of view.
Course timeDay 1 : 09h00 - 17h00 Day 2 : 09h00 - 15h00
Who should attend
- Medical Directors and others responsible for developing paediatric research portfolios
- Monitors and auditors responsible for overseeing paediatric research
- Paediatric research investigators, research coordinators and nurses
- Members of ethics committees reviewing paediatric research proposals
- Members from Regulatory bodies responsible for paediatric research
- Background and importance of the EU Paediatric regulation
- 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
- To identify cases in which paediatric research is needed
- To design paediatric research protocols that meet the needs of children as well as research institutions
- To identify the most important regulatory and ethical considerations in paediatric research design
- To establish well designed paediatric research programmes that are appropriately organized and which meet the practical needs of patients, families, researchers and sponsor organizations
- Understand the need and content of a paediatric investigational plan (PIP)
- Sharing best practices from an industry as well as regulators point of view