Fostering the scientific progress ensuring ethical and regulatory principles
REGULATORY SCIENCE
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.
Public consultations
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:
- EMA Survey on Orphan Maintenance Assessment Reports (OMARs) - (November, 2021)
- Linee guida AIFA per la compilazione del Dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale (September, 2020)
- Survey on the Pharmaceutical Strategy - Timely patient access to affordable medicines (September 2020)
- Comments to the EMA Discussion Paper “The General Data Protection Regulation: Secondary Use of Data for Medicines and Public Health Purposes” (July, 2020)
- Horizon Europe Co-design 2021 - 2024 (September, 2019)
- Discussion paper: use of patient disease registries for regulatory purposes - methodological and operational considerations (June, 2019)
- Public Consultation on EMA Regulatory Science to 2025 (June, 2019)
- HMA - EMA Consultation: Role of big data for evaluation and supervision of medicines in the EU (April, 2019)
- Open public consultation for the evaluation of the EU legislation on medicines for rare diseases and children (January, 2019)
- Role of big data for evaluation and supervision of medicines in the EU
Comments to 17/EN WP259 Guidelines on Consent under Regulation 2016/679 (2018) - Orphan Paediatric roadmap (2018)
- Public Consultation on the revision of Ethical Considerations for Clinical Trials on Medicinal products Conducted with Minors, August 2016
- EMA/44410/2014 Gaucher disease - A strategic collaborative approach from EMA and FDA, August 2014
- Revision of the Clinical Trials Directive 2001/20/EC concept paper submitted for public consultation, June 2013
The Foundation also contributed to other important public consultations, such as:
- Survey on expert panels (24/08/2018)
- The ENCePP Code of Conduct - For Scientific Independence and Transparency in the Conduct of Pharmacoepidemiological and Pharmacovigilance Studies (2018)
- Paediatric Regulation Consultation Questions and Responses MT 050217 (2017)
- ICH E11 (R1) guideline on clinical investigation of medicinal products in the pediatric population (2016/2017)
- Summary of Clinical Trial Results for Laypersons (August 2016)
- EnprEMA data collection for the 10 year report to the European Commission on the public health effects of the Paediatric Regulation (November 2015)
- Contribution to the topic of transition from paediatrics to adults clinical care settings by providing documents on Thalassaemia and HIV infection patients (May 2015)
- EnprEMA request for information to develop a Global Paediatric Clinical Trials Network (October 2014)
- Stakeholder consultation for Horizon 2020 Societal Challenge “Health, demographic change and wellbeing” for the programming exercise 2016/2017 (September 2014)
- Gaucher disease. A strategic collaborative approach from EMA and FDA (EMA/44410/2014)
- Contribution to amendments proposed by GRiP (FP7- HEALTH – 2010-261060) to the draft Regulation on Clinical Trials on medicinal products for human use (May 2013)
- Concept paper on extrapolation of efficacy and safety in medicine development (EMA/129698/2012)
- Concept paper on the involvement of children and young people at the Paediatric Committee (PDCO) (EMA/PDCO/388684/2012)
