Cargando…

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development pla...

Descripción completa

Detalles Bibliográficos
Autores principales:	Tafuri, Giovanni, Pagnini, Margherita, Moseley, Jane, Massari, Marco, Petavy, Frank, Behring, Antje, Catalan, Arantxa, Gajraj, Elangovan, Hedberg, Niklas, Obach, Mercè, Osipenko, Leeza, Russo, Pierluigi, Van De Casteele, Marc, Zebedin, Eva‐Maria, Rasi, Guido, Vamvakas, Spiros
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2016
Materias:	Clinical Trials
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137821/ https://www.ncbi.nlm.nih.gov/pubmed/27245362 http://dx.doi.org/10.1111/bcp.13023

Ejemplares similares

Expanding HTA – Correcting a Misattribution, Clarifying the Scope of HTA and CEA: Comment on "Ethics in HTA: Examining the ‘Need for Expansion’"
por: Culyer, Anthony J.
Publicado: (2019)

Navigating HTA implementation: a review of Indonesia’s revised HTA guideline
por: Chavarina, Kinanti Khansa, et al.
Publicado: (2023)

GMS-HTA: Information out of the world of HTA - up-to-date, comprehensive and valid
por: Rüther, Alric
Publicado: (2005)

Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies
por: Makady, Amr, et al.
Publicado: (2017)

HTA Training for Healthcare Professionals: International Overview of Initiatives Provided by HTA Agencies and Organizations
por: Hoxhaj, Ilda, et al.
Publicado: (2022)

The Impact of Brexit on Pharmaceuticals and HTA
por: Lorgelly, Paula K
Publicado: (2018)

Towards a more transparent HTA process in Poland: new Polish HTA methodological guidelines
por: Lach, Krzysztof, et al.
Publicado: (2017)

HTA and National Immunisation Program: an overview of competent bodies and of the impact of HTA on the decision-making process
por: Ricciardi, W
Publicado: (2022)

An EU-wide approach to HTA: An irrelevant development or an opportunity not to be missed?
por: Kanavos, Panos, et al.
Publicado: (2019)

The development of HTA collaboration at European level and the challenge of the EU regulation
por: Ruether, A, et al.
Publicado: (2022)

HTA26 Health Technology Assessment (HTA) Methods for Monoclonal Antibodies for Treatment and Prevention of COVID-19
por: Warttig, S, et al.
Publicado: (2022)

HTA253 Payer Perspectives on the Impact of the COVID-19 Pandemic on Health Technology Assessments (HTA) in Europe
por: Hutcheson, R, et al.
Publicado: (2022)

Use of Surrogate end points in HTA
por: Mangiapane, Sandra, et al.
Publicado: (2009)

Ethics in HTA: Examining the "Need for Expansion"
por: Abrishami, Payam, et al.
Publicado: (2017)

Impact of COVID-19 pandemic on HTA
Publicado: (2020)

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective
por: Kisser, Agnes, et al.
Publicado: (2021)

Ethical analysis in HTA of complex health interventions
por: Lysdahl, Kristin Bakke, et al.
Publicado: (2016)

HTA assessment of COVID-19 interventions in Ireland
Publicado: (2020)

Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit
por: Halmesmäki, Esa, et al.
Publicado: (2016)

Leveraging EUnetHTA’s conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer’s point of view
por: Giuliani, Giovanni, et al.
Publicado: (2018)

Bibliometrics of NIHR HTA monographs and their related journal articles
por: Royle, Pamela, et al.
Publicado: (2015)

Why not integrate ethics in HTA: identification and assessment of the reasons
por: Hofmann, Bjørn
Publicado: (2014)

Time to publication for NIHR HTA programme-funded studies
por: Chinnery, Fay, et al.
Publicado: (2013)

HTA Implementation Roadmap in Central and Eastern European Countries
por: Kaló, Zoltán, et al.
Publicado: (2016)

Patient advocate perspectives on involvement in HTA: an international snapshot
por: Scott, Anna Mae, et al.
Publicado: (2017)

Worldwide HTA access to ICER's cost-effectiveness models
Publicado: (2020)

HB-HTA as an implementation problem in Polish health policy
por: Gałązka-Sobotka, Małgorzata, et al.
Publicado: (2021)

Living HTA: Automating Health Economic Evaluation with R
por: Smith, Robert A., et al.
Publicado: (2022)

5.M. Workshop: The need to account for vaccine-specificities in the implementation of the EU Regulation on HTA
Publicado: (2022)

Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree
por: Dintsios, C. M., et al.
Publicado: (2019)

The impact of HTA reports on health policy: a systematic review
por: Gerhardus, Ansgar, et al.
Publicado: (2005)

Health technology assessment (HTA) increasingly important in spine research
por: van Tulder, Maurits
Publicado: (2011)

Role of NIHR HTA clinical trials on subsequent systematic reviews
por: Raftery, James, et al.
Publicado: (2015)

HTA and MCDA solely or combined? The case of priority-setting in Colombia
por: Castro, Héctor E., et al.
Publicado: (2018)

International HTA Experience with Targeted Therapy Approvals for Lung Cancer
por: Maraiki, Fatma, et al.
Publicado: (2018)

Evaluating facts and facting evaluations: On the fact‐value relationship in HTA
por: Hofmann, Bjørn, et al.
Publicado: (2018)

Equity in HTA: what doesn’t get measured, gets marginalised
por: Cookson, Richard, et al.
Publicado: (2017)

HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting
por: Garagiola, Elisabetta, et al.
Publicado: (2020)

POSC254 The Impact of COVID-19 on European HTA Decisions
por: Watson, C, et al.
Publicado: (2022)

HTA56 COVID-19 from the Perspective of Intellectual Property
por: Pereira da Veiga, CR, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_cu2vfa7t718fp2djpcmpujndbd