The 8th Foresight Training Course, a key training event on paediatric studies regulation, is taking place on 22nd and 23rd September in Warsaw, Poland.
The event, part of a series of annual courses organised by the Gianni Benzi Foundation, is titled “Regulatory and Practice in Paediatric Trials and Studies”.
It is organised by the Gianni Benzi Pharmacological Research Foundation in Italy and the Children’s Memorial Health Institute in Poland, in collaboration with the GRiP WP4 team, led by CVBF-Teddy in Italy.
The course will focus on four key topics in paediatric studies:
• How to plan and conduct paediatric trials
• Innovative studies’ designs to implement paediatric research
• From the protocol to the trial conduct
• Future of the paediatric research in a global context
The aim of the course to reflect on some of the key issues that will dramatically impact paediatric clinical re¬search in the coming years, beginning from the implementation of new European rules regulating clinical research, and in particular the new rules on clinical trials coming into effect in May 2016.
The faculty, which has long-standing expertise on these issues, will analyse how the provisions of the 2008 European Paediatric Recommendations will be implemented through the new regulation.
The background to the course is the ongoing debate on the impact of the Paediatric Regulation, which was implemented 10 years ago.
By January 2017, a report on the experience with rewards and incentives measures will be issued. The initiative, which involves several qualified stakeholders from different countries, should contribute to collect views and data supporting the maintenance of a strong EU paediatric initiative.
New forms of support, including research infrastructure and global networks, being devel-oped to promote paediatric clinical research.
A proposal for a European Paediatric Clinical Trials Research Infrastructure (EPCTRI) addressing paediatric research across Europe, with innovative scientific and methodological strategies, was recently submitted and is going through an evaluation process.
For the first time, an IMI (Innovative Medicines Initiative) call will specifically address the theme of paediatric research. Significant efforts at global level are also dedicated to creating new research platforms, such as the International Neonatal Consortium or the Global Pediatric Clinical Trial Network.
Suitable expertise to develop and exploit these instruments should be adequately trained, and the course will provide an opportunity to fulfill this need.
Please see the attached brochure and application form to find out more details on this important event, including how to participate.