Advanced therapy medicinal products. [PDF]
Eur J Hosp Pharm, 2023 15211545In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals - the advanced therapy medicinal products (ATMPs).
Lozano-Blázquez A +4 more
europepmc +6 more sources
RISK ASSESSMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS [PDF]
Безопасность и риск фармакотерапии, 2018 Advanced therapy medicinal products (ATMP) represent a heterogeneous group of medicinal products, combined with the need for special regulation of their circulation.
R. N. Alyautdin +5 more
doaj +2 more sources
Production Aspects of Advanced Therapy Medicinal Products
, 2022 Poster presented at the 2022 Conference of the European Association of Health Law (EAHL) in Ghent.
Veran, Julie +7 more
core +6 more sources
Advanced Therapy Medicinal Products and the Changing Role of Academia. [PDF]
Transfus Med Hemother, 2022 Academic institutions coin the ATMP landscape but do not possess an industry-like capacity to vigorously pursue the full developmental pathway to marketing authorization. At the same time, industry has fostered clinical trials with ATMPs, brought the first products to marketing authorization, and defined novel modes of interaction with academia.
Priesner C, Hildebrandt M.
europepmc +3 more sources
Advanced Therapy Medicinal Products: What's in a Name? [PDF]
Journal of Pharmaceutical Sciences, 2020 In this commentary I briefly discuss the term advanced therapy medicinal products (ATMPs). The last two words, medicinal products, correctly indicate that we are dealing with medicines. However, oftentimes ATMPs and products within the ATMP family are erroneously called therapies, which may raise confusion, as illustrated with some examples, and may ...
Jiskoot, W.
openaire +5 more sources
Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries [PDF]
Frontiers in Pharmacology, 2023 Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers.
Juan Carlos Rejon-Parrilla +7 more
doaj +2 more sources
Is it enough just to demonstrate that the advanced therapy medicinal products do work or we would prefer to keep walking on the Moon? [PDF]
Regenerative Therapy, 2023 After several decades of continuous yet bumpy progress the advanced therapy medicinal products reached the stage when the first drugs with well documented efficacy started to be registered.
Dinko Mitrečić
doaj +2 more sources
Advanced Therapy Medicinal Products Challenges and Perspectives in Regenerative Medicine. [PDF]
J Clin Med Res, 2020 Recently, the design and development of a modern health policy in the field of regenerative medicine leads to the formation of a new and integrated cognitive field, which requires systematic research and study in order to produce innovative answers and best practices.
Goula A +7 more
europepmc +4 more sources
The complex price setting and reimbursement of non-industrial advanced therapy medicinal products [PDF]
Health Economics ReviewBackground Advanced Therapy Medicinal Products (ATMPs) developed under the Hospital Exemption (HE) offer innovative treatments for patients with unmet medical needs, but their pricing and reimbursement (P&R) remain fragmented and poorly understood.
Zuzana Špacírová +2 more
doaj +2 more sources
Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries [PDF]
Regenerative Therapy, 2022 Introduction: Autologous chondrocytes (ACs) are Human cell/tissue-based products used for the treatment of joint cartilage defects. Regulatory agencies have established regulations related to ACs to ensure their safety and efficacy.
Jiwon Kim +3 more
doaj +2 more sources