Fondazione Penta Onlus

The Penta Foundation provides ethical, regulatory and legal oversight and guidance on all aspects of the EMPIRICAL project, throughout Work Package 5 activities. Safety and compliance with agreed principles, standards and codes of practice will be closely monitored and ethics, regulatory and legal requirements at each recruitment site will be applied overall the duration of the trial.

The close collaboration with HerpeZ Limited Zambia and the University of Zimbabwe will allow for the provision of tools to facilitate the accomplishment of all the ethics, regulatory and legal requirements mentioned above. All these activities are aimed at ensuring the welfare and the protection of the rights of children participating in the EMPIRICAL clinical trial.

About Penta
The Penta Foundation was set up in May 2004 as the Penta coordinating centre to support activities related to research on HIV and other paediatric diseases, primarily infectious diseases. Penta’s activities address a complex range of concerns, such as proposal drafting, scientific coordination, project implementation and data management. The Foundation is a promoter/sponsor of clinical trials according to the GCP guidelines and relevant European Directives; a centre for project development and management and for the collection and dissemination of information on HIV related issues.

Due to its unique expertise in running international research projects, the Foundation has established several links with research groups in order to manage EU and other funded projects (also beyond paediatrics) thus getting additional support for its infrastructure. It also coordinates training programmes for health providers.

The Penta Foundation has led more than 15 clinical trials in HIV-infected children in the past 25 years. Penta works with experts on regulatory and ethical issues to ensure the conduct of high quality clinical research and training. The activity of Penta ID network, which brings together key stakeholders, acts as an important support for communication and dissemination activities.

The Penta Foundation has led more than 15 clinical trials in HIV-infected children in the past 25 years. Penta counts with experts on regulatory and ethical issues that permit to carry out high quality clinical research and training. The activity of Penta ID network, which brings together key stakeholders, acts as an important support for the communication and dissemination activities.

penta-id.org

Researchers

LAURA MANGIARINIPrincipal Investigator

Laura Mangiarini is the Chief Operating Officer at the Penta Foundation. She has a Master’s degree in Regulatory Affairs and a PhD in Advanced Biotechnologies, as well as a Master’s degree in Molecular Biology. She has been Project coordinator in several EU-funded paediatric projects and has extensive experience in R&D and Regulatory Affairs.

DANIEL JOSÉ GÓMEZFinancial Manager

Daniel José Gómez has a Master’s degree in Business Administration and Management and has extensive experience working as financial Manager in several FP7, H2020 and IMI2 projects. In the past, he has also acted as Project Manager in paediatric clinical trials in the field of HIV.

ALESSANDRA NARDONERegulatory Affair & QA Manager

Alessandra Nardone is the Regulatory Affairs and Quality Assurance Manager at the Penta Foundation. She has Master’s degrees in Pharmacovigilance and Regulatory Affairs and also in Pharmaceutical Chemistry and Technology.