Cargando…

An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology

BACKGROUND: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand the effectiveness and efficiency of the processes implemented by the Caribbean Regulatory System for the...

Descripción completa

Detalles Bibliográficos
Autores principales:	Liberti, Lawrence, Extavour, Rian Marie, Patel, Prisha, McAuslane, Neil
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2020
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487479/ https://www.ncbi.nlm.nih.gov/pubmed/32939288 http://dx.doi.org/10.1186/s40545-020-00261-z

Ejemplares similares

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)

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)

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)

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

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

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)

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

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature
por: Bujar, Magdalena, et al.
Publicado: (2017)

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

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)

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)

OP Transcon 2018 Compilation
Publicado: (2019)

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)

Suite from the opera Colas Breugnon (Master of Clamecy), op. 24, after the story by Romain Rolland
por: Kabalevsky, Dmitry Borisovich, 1904-1987
Publicado: (1946)

Regulatory measures to fight obesity in Small Island Developing States of the Caribbean and Pacific, 2015 – 2017
por: Foster, Nicole, et al.
Publicado: (2018)

La ópera hoy, la ópera ayer, la ópera siempre : antología de crónicas /
por: Lizalde, Eduardo
Publicado: (2003)

Opera
por: Donizetti, Gaetano

Opera/
por: Kurferberg, Herbert
Publicado: (1975)

OPERA
por: De Serio, M
Publicado: (2003)

OPERA
por: Stefano, Dusini
Publicado: (2012)

L'opéra et l'opéra-comique /
por: Dumesnil, René, 1879-1967
Publicado: (1971)

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)

La ópera
por: Ceballos, Edgar
Publicado: (2002)

The beggar's opera /
por: Havel, Václav
Publicado: (2001)

The threepenny opera /
por: Brecht, Bertolt, 1898-1956
Publicado: (1994)

Literature as opera /
por: Schmidgall, Gary, 1945-
Publicado: (1977)

Opera Omnia
por: Morales, Cristóbal de, aproximadamente 1500-1553
Publicado: (1959)

Opera medicinalia /
por: Bravo, Francisco, fl. ca. 1553
Publicado: (1994)

Opera arias
Publicado: (1989)

Opera historica
por: Bede the venerable Santo 673?-735
Publicado: (1930)

Aristotelis Opera.
Publicado: (1960)

Opera matematica.
por: Vranceanu, Gheorghe
Publicado: (1969)

Opera choruses
por: Verdi, Giuseppe, 1813-1901
Publicado: (1990)

Opera postuma
por: Talbot, Charles H.
Publicado: (1979)

Backstage at OPERA
Publicado: (2003)

OPERA experiment
por: Komatsu, M
Publicado: (2003)

The Castrati in opera/
por: Heriot, Angus

Introduction to Opera/
por: Peltz, Mary Ellis

Cannot write session to /tmp/vufind_sessions/sess_7aglf9dia4edlgcfee8qb9rnpr