This training focuses on the pediatric regulations and their practical implementation. If you want to know more about the ins and outs of Pediatric 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 a seasoned pharma industry expert
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 importance of paediatric research, PIP development and a brand-new session sharing best practices from an Industry and Regulators point of view.