Cargando…

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the...

Descripción completa

Detalles Bibliográficos
Autores principales:	Bujar, Magdalena, McAuslane, Neil, Walker, Stuart R., Salek, Sam
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2017
Materias:	Pharmacology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5385334/ https://www.ncbi.nlm.nih.gov/pubmed/28443022 http://dx.doi.org/10.3389/fphar.2017.00189

Ejemplares similares

The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines
por: Bujar, Magdalena, et al.
Publicado: (2019)

A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines
por: Bujar, Magdalena, et al.
Publicado: (2020)

Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation
por: Bujar, Magdalena, et al.
Publicado: (2020)

Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa
por: Keyter, Andrea, et al.
Publicado: (2020)

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines
por: Liberti, Lawrence, et al.
Publicado: (2017)

The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions
por: Bujar, Magdalena, et al.
Publicado: (2021)

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities
por: McAuslane, Neil, et al.
Publicado: (2023)

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016
por: Kühler, Thomas Christian, et al.
Publicado: (2019)

Companies’ Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study
por: Wang, Ting, et al.
Publicado: (2020)

The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making
por: Donelan, Ronan, et al.
Publicado: (2016)

A practical approach to communicating benefit-risk decisions of medicines to stakeholders
por: Leong, James, et al.
Publicado: (2015)

An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology
por: Liberti, Lawrence, et al.
Publicado: (2020)

Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
por: Leong Wai Yeen, James, et al.
Publicado: (2014)

Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
por: Rodier, Céline, et al.
Publicado: (2020)

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access
por: Keyter, Andrea, et al.
Publicado: (2021)

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries
por: Owusu-Asante, Mercy, et al.
Publicado: (2022)

Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality
por: Hashan, Hajed M., et al.
Publicado: (2022)

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry
por: Owusu-Asante, Mercy, et al.
Publicado: (2023)

Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile
por: Wang, Ting, et al.
Publicado: (2022)

The South African Regulatory System: Past, Present, and Future
por: Keyter, Andrea, et al.
Publicado: (2018)

The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland
por: Keyter, Andrea, et al.
Publicado: (2019)

Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
por: Jonker, Carla J., et al.
Publicado: (2022)

A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016
por: Patel, Prisha, et al.
Publicado: (2020)

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology
por: Sani, Noraisyah Mohd, et al.
Publicado: (2020)

Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities
por: Sithole, Tariro, et al.
Publicado: (2021)

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment
por: Malinowski, Krzysztof Piotr, et al.
Publicado: (2018)

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System
por: Keyter, Andrea, et al.
Publicado: (2018)

Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication?
por: Keyter, Andrea, et al.
Publicado: (2020)

Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe
por: Vreman, Rick A., et al.
Publicado: (2020)

A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
por: Allen, Nicola, et al.
Publicado: (2017)

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
por: Rahalkar, Hasumati, et al.
Publicado: (2021)

Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines
por: Koyuncu, Oguzhan, et al.
Publicado: (2020)

Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward
por: Ngum, Nancy, et al.
Publicado: (2022)

Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement
por: Ngum, Nancy, et al.
Publicado: (2022)

A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency
por: Keyter, Andrea, et al.
Publicado: (2020)

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
por: Rahalkar, Hasumati, et al.
Publicado: (2018)

Factors Influencing Delays in Patient Access to New Medicines in Canada: A Retrospective Study of Reimbursement Processes in Public Drug Plans
por: Salek, Sam, et al.
Publicado: (2019)

Health Economic Data in Reimbursement of New Medical Technologies: Importance of the Socio-Economic Burden as a Decision-Making Criterion
por: Iskrov, Georgi, et al.
Publicado: (2016)

Traditional Chinese Medicine Regulating Lymphangiogenesis: A Literature Review
por: Peng, Longping, et al.
Publicado: (2020)

Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines
por: Keyter, Andrea, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_d9nj7ks6p97n1gdlb0v0jr987l