Good design practices for an integrated containment and production system for advanced therapies

C Zanini, F Severina, G Lando… - Biotechnology and …, 2020 - Wiley Online Library
… Furthermore, working with closed systems can optimize and facilitate the production of
Advanced Therapy Medical Products in GMP environments, by providing an easily reproducible …

[PDF][PDF] 15. Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

R Kahveci, W Oortwijn, B Godman, EM Koç, B Tibet - 2018 - core.ac.uk
… It prepares HTA reports either at G-BA requests or self-initialized (for non-pharmaceutical
products) [40]. It does not have any decision-making powers and its advice to the G-BA (eg …

HTA100 Health Technology Assessment Paradigm in Rare Diseases: Critical Determinants and Recommendations

P Jain, S Pandey, A Ostawal - Value in Health, 2023 - valueinhealthjournal.com
… of carer burden in health technology assessments (HTA) in … of carer burden could
impact gender health inequality. … retrieved from value dossiers of 17 medicinal products (n=46 …

Proposal for a regulation on health technology assessment in Europe–opinions of policy makers, payers and academics from the field of HTA

P Vella Bonanno, A Bucsics, S Simoens… - Expert review of …, 2019 - Taylor & Francis
… specificities of the products which are always developing, eg with the introduction of
different advanced therapy medicinal products (ATMPs) including gene therapies [Citation66–…

Gene therapy evidence generation and economic analysis: pragmatic considerations to facilitate fit-for-purpose health technology assessment

T Qiu, M Pochopien, S Liang, G Saal… - … in Public Health, 2022 - frontiersin.org
… GTs have challenged their evaluations in health technology assessment (HTA); hence…
Advanced therapy medicinal products and health technology assessment principles and practices

Determinants of Managed Entry Agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries

O Efthymiadou, P Kanavos - … of technology assessment in health …, 2021 - cambridge.org
… entry of new pharmaceutical products and mitigate risks related to premature evidence (7;8);
one way to achieve this has been through the introduction of contractual arrangements …

Commissioning and qualification of process equipment for the manufacturing of advanced therapy medicinal products

A Nygård - 2024 - doria.fi
Advanced therapy medicinal products are complex in nature, with risks varying
depending on the product type, characteristics of starting materials, and the complexity of the …

Medical affairs and innovative medicinal product strategy development

A Krendyukov, D Nasy - Pharmaceutical Medicine, 2022 - Springer
… on how best to use InMPs and communicate the value of products to external stakeholders,
including Health Technology Assessment bodies. In addition, insights from post-approval …

Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement

T Wang, N McAuslane, WG Goettsch… - … Assessment in Health …, 2023 - cambridge.org
… -wide added value or research priorities; and breakthrough technology for oncology products
and/or advanced therapy medicinal products (34). The criteria ensured that the resources …

Comparison of new Brazilian legislation for the approval of advanced therapy medicinal products with existing systems in the USA, European Union and Japan

KLG Gomes, RE da Silva, JB da Silva Junior… - Cytotherapy, 2022 - Elsevier
… of biotechnological techniques have led to the development of innovative therapies known
as advanced therapy medicinal products (ATMPs), which are a class of biological products for …