Fondazione Gianni Benzi delivers educational and training activities with the aim to foster a continuous multi-specialistic update on the most recent novelties in the healthcare sector through the exchange of experiences and knowledge among companies, academics, regulators and patients.
Annually, Fondazione Gianni Benzi organises the Foresight Training Course (FTC), a short international course aimed to promote pharmacological research and innovation.
FTC AGENDA
- I FTC – European centralised procedure and Paediatric Regulation
- II FTC – Advanced Therapies and Orphan Drugs
- III FTC – Benefit/Risk assessment of medicines to achieve shared objectives: from research to reality
- IV FTC – Evidences for rational therapies: from newborn to elderly population
- V FTC – Science, regulation and business in pharmacotherapies: how to solve conflicts and exploit synergies for the benefits of patients
- VI FTC – Biotech and innovative science to meet patients’ needs
- VII FTC – Health and biotechnology
- VIII FTC – Regulatory and practice in paediatric trials and studies
- IX FTC – Europe leads the best medicines system for patients
- X FTC – The European Medicine Regulatory Network: present and future
- XI FTC – Change in regulatory sciences in the EU – how to move from a reactive to a multistakholders proactive attitude
- XII FTC – Innovative medicine and research: ethical, legal and regulatory issues
- XIII FTC - Challenges for Researchers and Regulators facing the pandemic crisis
- XIV FTC - The health emergency: regulatory crash and future perspectives
- XV FTC - Boosting research and innovation in a changing regulatory framework
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Regulatory Sciences
- FTC XIV | Data space and regulatory decision making (Ine Skottheim Rusten)
- FTC XIV | Regulatory process in the COVID 19 era: how to deal with the organisational and scientific challenges at the European Medicines Agency level (Fergus Sweeney)
- FTC XIII | The EMA regulatory framework for timely approval of new and innovative drugs and vaccines in the pandemic era (Cavaleri Marco)
- FTC XIII | Pharmaceutical Strategy for Europe (D'Atri Fabio)
- FTC XII | Legal and regulatory issues dealing with paediatric translational research in the EPTRI framework (Tzortzatou Olga)
- FTC XI | Presentation of a COST proposal (Giannuzzi Viviana)
- FTC XI | The evolving role of healthcare professionals in the regulatory field (Migliaccio Giovanni)
Research Methodology
- FTC XIV | The opportunity of decentralized Clinical Trials in rare diseases: the PRONTO study (Stefano Portolano)
- FTC XIV | Decentralized Clinical Trials: strengths and weakness of safety management (Maria Grazia Felisi)
- FTC XIII | Vaccine Development For Emerging Infectious Diseases (Gambotto Andrea)
- FTC XII | Access to personal data for scientific research in the perspective of developing innovative medicine (Herveg Jean)
- FTC XI | The demonstration of significant benefit in the EU framework (Fregonese Laura)
- FTC X | Gain evidence from Innovative study designs for clinical trials (Baiardi Paola)
- FTC X | Experimental and real world data: collect, archive and share to increase their value in research (Bonifazi Duccio)
- FTC X | Sharing and re-use of individual participants data from clinical trials (Demotes Jacques)
- FTC X | Data Protection and Privacy: the new General Data Protection Regulation (GDPR) - (Spina Alessandro)
- FTC X | Harnessing the power of Real World Data (Pasciullo Gabriella)
- FTC X | OMP registries: are they a tool to cover the gap? (Giannuzzi Viviana)
Paediatric Medicines
Orphan Medicines
- FTC XIII | Orphan Regulation faced with changes in the EU pharmaceutical system (Giannuzzi Viviana)
- FTC XIII | The European pharmaceutical system: strengths and weaknesses: Specificities of rare diseases (Houyez François)
- FTC XII | Health vulnerability and the European framework on access to orphan medicine (Gennet Eloise)
- FTC XII | Orphan Medicinal products and health budgets (Houÿez François)
- FTC XI | The complexity of developing innovative medicines for rare diseases (Ardigò Diego)
- FTC XI | Oprhan Medicines Development - The science of hope (Athanasiou Dimitrios)
- FTC XI | Developing Advanced therapies for rare diseases in EU: opportunities and challenges in the experience of a Charity (Gabaldo Michela)
- FTC XI | Researchers, networks, new funds for rare diseases (Julkowska Daria)
- FTC XI | Expectations from the revision of the System (Bosone Enrico)
- FTC XI | Regulation (EC) 141/2000 (Giannuzzi Viviana)
Data science
- FTC XIV | Real use of real world data (Fedele Bonifazi)
- FTC XIV | Real-World Evidence Data in a Drug Submission Process: the EMA vs. FDA perspective (Luca Pani)
- FTC XIV | FAIR in practice: The Duchenne Data Platform (Nawel van Lin)
- FTC XIV | Federated Learning as a Tool for Gathering Knowledge from Multiple Data Sources (George Drosatos)
- FTC XIV | AI for drug efficacy and safety (Aris Persidis)
- FTC XII | Machine Learning System applied to health data and systems (Bonifazi Duccio)
- FTC XI | Big Data & Life Science (Pesole Graziano)
- FTC XI | Data science supporting medicines and healthcare development - Industry perspective and Novartis experience (Orsenigo Roberto)
Patients empowerment
- FTC XI | EMA experience in supporting participation of patients and healthcare professionals in EU medicines regulation (Silva Ivana)
- FTC XI | How has the role of patients got stronger and what they – and regulators have learnt so far (Houyez François)
- FTC X | Experiences in advocay for Patients' rights (Quaggia Daniela)
- FTC X | Contribution of expert patients in the assessment process of innovative medicine (Brunetta Angelo Loris)
- FTC X | Medicine Agencies responsibility of keeping patients informed while covering their needs (Clieslik Anna)
- FTC X | Protect the experimental patients population: a key role for Ethics Committees (Marek Migdal)
- FTC X | Involve the younger in safe medicinal development plans (Ruggieri Lucia, Mariangela Lupo)
Medical Device
- FTC XI | EU Regulation on Medical Devices 2017/745 – Novelties and implementation (Fraser Alan)
- FTC XI | The new regulation and the management of software and applications (Garufi Cettina)
- FTC XI | The new regulations on medical devices and on in vitro diagnostics: a real revolution? (Gattafoni Franco)
- FTC XI | The manufacturing and control of medical devices in the perspective of the new regulation (Geremia Fabio)
- FTC XI | The new provisions introduced by Rule 21 (Mamoli Antonella)
HTA and market access
- FTC XIII | The European pharmaceutical system: strengths and weaknesses: Company perspective (Hebborn Ansgar)
- FTC XIII | The increased value of the EC consultation to promote the new strategy (Giannuzzi Viviana, Bosone Enrico)
- FTC XII | Health Technology Assessment (HTA) and Access Policies (Stühlinger Verena)
- FTC XII | Exploring solutions to foster ATMP's development and access to patients in Europe (Salvatore Vincenzo)
- FTC X | Timely access to therapies for severe diseases with unmet medical needs (Bosone Enrico)
- FTC X | Outcome research and outcome management in the light of Health Assessment: the case of Fall Prevention (Springhetti Isabella)
- FTC X | Health technology Assessment (HTA) criteria in light of current R&D trends (Patroncini Mauro)
- FTC X | HTA scientific network with HTA bodies, payers and patients (Dziurda Dominik)
