Fostering the scientific progress ensuring ethical and regulatory principles
Promoting compliance with European standards on ethical and regulatory procedures is one of our main activities.
In this field, we contribute to many international research collaborative projects requiring regulatory and ethical support. We are actively involved in the preparation of Paediatric Investigational Plans, Orphan Designation procedure, guide documents and templates for informed consent and paediatric assent forms, as well as material and data transfer agreement.
Moreover, our representatives as experts in the regulatory field, serve or served as members of the Paediatric Committee at the European Medicines Agency, and other relevant scientific committees and working groups at the Italian Medicines Agency, the Italian National Agency for Regional Health Services and the Regional Agency for Health and Social Care of Puglia - Italy.
FORESIGHT TRAINING COURSES
We annually promote and organise the Foresight Training Courses (FTCs), short international courses aimed at training high-specialized professional profiles in the different fields of regulatory sciences.
The FTCs aim to deepen and disseminate regulatory innovations for the development and marketing of drugs and other innovative health products at European level, but also to encourage the involvement of the main stakeholders (regulatory experts from Agencies and industries, patients, healthcare professionals, non-profit organisations and researchers from academia) at all stages of the development of products for human health.
The XVI Foresight Training Course will be held on 18 December 2023.
The consolidated expertise makes Fondazione Gianni Benzi an authoritative voice at European level in the ethical and regulatory framework. Such an experience results into documents processing and concrete participation in public consultations launched by the competent authorities on different topics of our interest: ethics, paediatrics and rare diseases policies, clinical trials, preclinical studies, privacy and confidentiality and patients’ empowerment in drug development.
This is the list of the public consultations where the Gianni Benzi Foundation directly participated in: