The regulation of cell therapy and gene therapy products in Switzerland
PK Bukovac, M Hauser, D Lottaz, A Marti… - … Cell Therapy Products …, 2023 - Springer
… information on a health technology assessment (HTA) … for the regulation of Advanced Therapy
Medicinal Products (ATMPs) in … products (TP), gene therapy medicinal products (GT) and …
Medicinal Products (ATMPs) in … products (TP), gene therapy medicinal products (GT) and …
Evaluating the Value for Money of Precision Medicine from Early Cycle to Market Access: a comprehensive review of approaches and challenges
… Health technology assessment (HTA) is a systematic and … how health technologies can
be used across different health … and development resources, product profile development, …
be used across different health … and development resources, product profile development, …
Prospects for harmonizing regulatory science programs in Europe, Japan, and the United States to advance regenerative medicine
CP Milne, J Mittra, N Kojima… - Therapeutic …, 2016 - journals.sagepub.com
… was its applicability to advanced technologies in Europe through the adoption in 2007 of
Regulation (EC) 1394/2007 on Advanced Therapy Medicinal Products (ATMP Regulation), …
Regulation (EC) 1394/2007 on Advanced Therapy Medicinal Products (ATMP Regulation), …
[HTML][HTML] Guidance for the harmonisation and improvement of economic evaluations of personalised medicine
H Vellekoop, S Huygens, M Versteegh… - …, 2021 - Springer
… standards for health technology assessment (… evaluation of interventions in a range of
PM-related fields, such as genomic technologies [13], advanced therapeutic medicinal products …
PM-related fields, such as genomic technologies [13], advanced therapeutic medicinal products …
[HTML][HTML] Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider
Y Sato, H Bando, M Di Piazza, G Gowing, C Herberts… - Cytotherapy, 2019 - Elsevier
… Health, Labour and Welfare (MHLW); and others, have introduced specific legislation and
guidelines to support the development of cell therapy medicinal products … advanced therapies, …
guidelines to support the development of cell therapy medicinal products … advanced therapies, …
[HTML][HTML] Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment
… the Next Generation Health Technology Assessment to support patient-centered, societally
oriented, real-time decision-making on access to and reimbursement for health technologies …
oriented, real-time decision-making on access to and reimbursement for health technologies …
[PDF][PDF] An Idea About Utilization of Medical Technologies and Devices in Therapeutics and Diagnostic
S Sastry, B Suresh - tbeah.org
… Health technology assessment also has been considered in … of health technologies that
includes medicinal products, … Robotic surgery is one of the best examples of therapeutic medical …
includes medicinal products, … Robotic surgery is one of the best examples of therapeutic medical …
DEVELOPMENT OF A REGULATORY GUIDELINEFOR CELL THERAPY MEDICINAL PRODUCTS IN THAILAND
P KIDPUN, R Chalongsuk - 2022 - ithesis-ir.su.ac.th
… to the emergence of Advanced Therapy Medicinal Products (ATMPs). These ATMPs entail
cell therapy medicinal products. These are emergence of new products. The objective of the …
cell therapy medicinal products. These are emergence of new products. The objective of the …
Novel policy options for reimbursement, pricing and procurement of AMR health technologies
S Vogler, K Habimana, S Fischer, MA Haasis - 2021 - jasmin.goeg.at
… countries perform Health Technology Assessments (HTA). In an HTA, the cost-effectiveness
of the health technology is studied, taking into consideration its (added) therapeutic benefit (…
of the health technology is studied, taking into consideration its (added) therapeutic benefit (…
The Advanced Therapies Treatment Centers and Their Network: A Model for the Accelerated Adoption of Advanced Therapies
M Whitaker - Human Gene Therapy, 2022 - liebertpub.com
… Therapy Catapult's (CGTC's) Annual Review that year identified 30 new advanced therapeutic
medicinal product (… scanning, health technology assessment, and submissions and the …
medicinal product (… scanning, health technology assessment, and submissions and the …