Fondazione Gianni Benzi realizza attività educative e formative in ambito regolatorio con l'obiettivo di favorire un continuo aggiornamento multi-specialistico sulle più recenti novità in quest'ambito attraverso lo scambio di esperienze e conoscenze tra aziende, accademici, regolatori e pazienti.
Ogni anno la Fondazione Gianni Benzi organizza il Foresight Training Course (FTC), un breve corso internazionale finalizzato alla promozione dell’innovazione e della ricerca farmacologica e sanitaria.
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
Apprezzeremmo un contributo volontario per supportare le nostre attività.
Per favore, compila il form sottostante per accedere al materiale.
Scienze Regolatorie
- 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)
Metodologia della ricerca
- 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)
Farmaci pediatrici
Farmaci orfani
- 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 e accesso sul mercato
- 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 (Patrocini Mauro)
- FTC X | HTA scientific network with HTA bodies, payers and patients (Dziurda Dominik)
