Description

Clinical Research Related Courses
Part of a STAR Programme

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.

Course time
Day 1 : 09h00 - 17h00 / Day 2 : 09h00 - 15h00
Who should attend
  • 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



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
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

 

Competencies

This course covers competencies that are part of the ECCRT Competency Framework

  • Scientific Concepts & Research Design (4)
  • Ethical & Participants Safety Considerations (6)
  • Investigational Product Development and Regulation (4)
  • Clinical Studies Operations (GCPs or ISO 14155) (2)
  • 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

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.

Booking is desired 1 week before F2F session in order to allow the participant to go through pre-read materials.
1 500,00 € excl. VAT (if applicable)