Advanced therapies, market developments, and sustainable access to cures
De Seta, Enrico (A.A. 2022/2023) Advanced therapies, market developments, and sustainable access to cures. Tesi di Laurea in Markets,regulations and law, Luiss Guido Carli, relatore Luca Arnaudo, pp. 111. [Master's Degree Thesis]
Full text for this thesis not available from the repository.
Abstract/Index
Advanced therapy medicinal products: overview and regulatory pathway. Definition of advanced therapy medicinal products. Introduction to ATMP regulatory framework. European regulatory actions for rare diseases and paediatric patients. ATMP classification criteria. EU legislative framework applicable to ATMPs: evolution of ATMP regulatory body. Pharmacovigilance legislation. Good manufacturing practices and good practice requirements. Clinical trials and EU Marketing authorisation (MA). ATMP borderlines. ATMP European price and reimbursement (P&R): management entry agreements perspective. Challenging accessibility to innovative medical products. ATMP market growth. Methods and approaches for economic analysis of medical products. European ATMP economic perspective and HTA activity. Management entry agreements (MEA). ATMP price and reimbursement in Europe. ATMP price and reimbursement in Italy. Addressing the economic unsustainability of ATMPs: withdrawal, decentralized manufacturing, orgenesis business model. Regulatory evolution and economic viability: implications for ATMPs. Unravelling the dynamics of ATMP withdrawal: consequences and strategies for effective management. Exploring decentralized manufacturing strategies for advanced therapy medicines. Advanced therapy manufacturing: the orgenesis approach to decentralized production.
References
Bibliografia: pp. 91-106.
| Thesis Type: | Master's Degree Thesis |
|---|---|
| Institution: | Luiss Guido Carli |
| Degree Program: | Master's Degree Programs > Master's Degree Program in Management, English language (LM-77) |
| Chair: | Markets,regulations and law |
| Thesis Supervisor: | Arnaudo, Luca |
| Thesis Co-Supervisor: | Colangelo, Giuseppe |
| Academic Year: | 2022/2023 |
| Session: | Summer |
| Deposited by: | Alessandro Perfetti |
| Date Deposited: | 30 Jan 2024 09:17 |
| Last Modified: | 30 Jan 2024 09:17 |
| URI: | https://tesi.luiss.it/id/eprint/37796 |
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