Regulation, policy, and governance of advanced therapies
J Mittra - The New Health Bioeconomy: R&D Policy and …, 2016 - Springer
… health technology assessment (HTA) and the perceived need for new, innovative policies and
valuation practices to better support therapeutic … any advanced therapy medicinal product, …
valuation practices to better support therapeutic … any advanced therapy medicinal product, …
[PDF][PDF] The value and measurement of innovation in health technology assessment and its impact on public financing of medicines
JC Rejón Parrilla - 2024 - digibug.ugr.es
… Finally, the third chapter investigates the P&R landscape for Advanced Therapy Medicinal
Products (ATMPs) in 20 countries. With ATMPs often having limited evidence at launch, the …
Products (ATMPs) in 20 countries. With ATMPs often having limited evidence at launch, the …
Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements
H Sievers, A Joos, M Hiligsmann - … Technology Assessment in Health …, 2021 - cambridge.org
… of Advanced Therapy Medicinal Products (ATMPs) (19). Additionally, RWD collection is
often linked to managed entry agreements and conditional marketing approvals. In comparison, …
often linked to managed entry agreements and conditional marketing approvals. In comparison, …
[HTML][HTML] Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe
KP Malinowski, P Kawalec, W Trąbka… - Orphanet journal of rare …, 2020 - Springer
… In most situations, orphan drugs must show cost-effectiveness in order to be … medicinal
products. In general, the same reimbursement rules apply to both orphan and non-orphan drugs …
products. In general, the same reimbursement rules apply to both orphan and non-orphan drugs …
Marketing regulatory oversight of advanced therapy medicinal products in Europe
M Schuessler-Lenz, C Herberts, I Reischl… - … Cell Therapy Products …, 2023 - Springer
… Union (EU) as medicinal products since 2003, when they were … for regulating advanced
therapy medicinal products (ATMP) … cell therapy, ATMP also include tissue-engineered medicinal …
therapy medicinal products (ATMP) … cell therapy, ATMP also include tissue-engineered medicinal …
Call for more effective regulation of clinical trials with advanced therapy medicinal products consisting of or containing genetically modified organisms in the European …
…, European Federation of Pharmaceutical … - … Gene Therapy, 2021 - liebertpub.com
… Medicinal Products Which Have the Potential to Treat, Modify, Reverse or Cure Serious …
Advanced therapy medicinal products (ATMPs) are innovative medicinal products that have …
Advanced therapy medicinal products (ATMPs) are innovative medicinal products that have …
Therapeutic Proteins and Advanced Therapy Medicinal Products
M Eppink, M Wapenaar, D Crommelin, A Hawe… - … of Medicinal Products, 2023 - Springer
… The second part of the chapter is devoted to the discussion of Advanced Therapy Medicinal
Products (ATMPs). These are medicines made from, or consisting of, cells, genes or tissues. …
Products (ATMPs). These are medicines made from, or consisting of, cells, genes or tissues. …
… Annual Meeting of the Safety Pharmacology Society: regulatory and safety perspectives for advanced therapy medicinal products (cellular and gene therapy products)
I Cavero, D Seimetz, D Koziel… - … Opinion on Drug …, 2020 - Taylor & Francis
… (ATMPs) and cell gene therapeutic products (CGTPs). ATMPs and … therapy medicinal
products, tissue-engineered products, or the incorporation of one of these products into a medical …
products, tissue-engineered products, or the incorporation of one of these products into a medical …
Early dialogues for pharmaceutical products in european network for health technology assessment joint action 3: what was done and where to go in the future
M Galbraith, C Guilhaume, C Bélorgey - … of Technology Assessment …, 2022 - cambridge.org
… Network for Health Technology Assessment (EUnetHTA) (1). … technical cooperation on
health technology assessment (HTA) … between Applicants (health technology developers [HTDs] …
health technology assessment (HTA) … between Applicants (health technology developers [HTDs] …
[HTML][HTML] Do advanced therapies have a future in the low-and middle-income countries-The case of Bulgaria, Romania, and Poland
M Kamusheva, A Turcu-Stiolica, J Gierczyński… - … in Public Health, 2021 - frontiersin.org
… countries for health technology assessment (HTA) of advanced therapies focusing on …
Advanced therapy medicinal products and health technology assessment principles and practices …
Advanced therapy medicinal products and health technology assessment principles and practices …