Use of Real-World Evidence in Health Technology Assessment Submissions

Y Liu, J Ma - Real-World Evidence in Medical Product Development, 2023 - Springer
… of post-launch RWE for Advanced Therapy Medicinal Products (ATMPs). IQWiG followed up
… be used to conduct added benefit assessments for new drugs, especially in scenarios where …

HTA methodology and value frameworks for evaluation and policy making for cell and gene therapies

D Coyle, I Durand-Zaleski, J Farrington… - … Journal of Health …, 2020 - Springer
… Several experts in health technology assessment and clinical experts … therapies are classed
as advanced therapeutic medicinalproducts, somatic cell therapy medicinal products, tissue-…

[PDF][PDF] Life Cycle of CAR-T cell products: Legal framework and points to consider during the life of a CAR-T cell product

H Springer-Frauenhoff - researchgate.net
… specific risks for each phase in the life of these advanced therapeutic medicinal products. …
or joint consulting with health technology assessment bodies (HTA) are discussed in 3.5.2. …

[PDF][PDF] Cell Therapy Report on Current Guidelines Regarding Advanced Cell Therapy Pre-clinical Safety, Efficacy and Potency Testing

AM Dickinson, D Caufield, J Campbell - alcyomics.com
… Somatic cell therapy medicinal product is also defined in Directive 2001/83/EC, Annex I, … of
13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83…

Principal criteria for evaluating the quality, safety and efficacy of hMSC-based products in clinical practice: current approaches and challenges

JA Guadix, J López-Beas, B Clares, JL Soriano-Ruiz… - Pharmaceutics, 2019 - mdpi.com
… as new therapeutic alternatives in advanced therapies and regenerative medicine thanks to
… As for their legal status, the leading health agencies classify them as medicinal products or …

New trends and challenges in the European regulation of innovative medicines

H Enzmann - Regulatory Toxicology and Pharmacology, 2016 - Elsevier
… Objectives and decision criteria of the stakeholders in this process, eg health technology
assessment (HTA) bodies, payers, physicians and patients, vary and may result not only in …

Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union

É Gennet, A Mahalatchimy, M Frischhut, PL Lau… - 2022 - shs.hal.science
… establishing a network of advanced therapies centres in the … in the view of health technology
assessment when relevant; b. … therapy medicinal products. Positive actions can and should …

The feasibility of health technology assessment in the Ghanaian health system

R Addo - 2019 - opus.lib.uts.edu.au
… Training Program, and the University of Technology Sydney (UTS) Business Doctoral … Fund,
Health technology assessment international travel grant and African Health Economics and …

Special treatment? Flexibilities in the politics of regenerative medicine's gatekeeping regimes in the UK

A Faulkner - Science as Culture, 2019 - Taylor & Francis
… regulation, health technology assessment and health-care … entry of medical products to the
EU (and thus in principle the … on pharmaceutical and Advanced Therapy Medicinal Product

The sandbox approach and its potential for use in health technology assessment: a literature review

E Leckenby, D Dawoud, J Bouvy, P Jónsson - Applied health economics …, 2021 - Springer
assessment and funding new technologies, including AI-based digital technologies and
advanced therapy medicinal products, before their widespread adoption and implementation [9]. …