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Journal of Pharmaceutical Policy and Practice
|
September 17, 2020
An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017-2018 using the OpERA methodology
Lawrence Liberti, Rian Marie Extavour, Prisha Patel, et al.
BMJ Open
|
November 28, 2019
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
Thomas Christian Kühler, Magda Bujar, Neil McAuslane, et al.
Therapeutic Innovation & Regulatory Science
|
September 21, 2018
An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency
Petra Dörr, Alison Wadworth, Tina Wang, et al.
Therapeutic Innovation & Regulatory Science
|
February 3, 2020
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways
Lawrence Liberti, Neil McAuslane, Pieter Stolk, et al.
Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|
June 19, 2018
Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions
Ting Wang, Neil McAuslane, Lawrence Liberti, et al.
Therapeutic Innovation & Regulatory Science
|
September 18, 2018
A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
Stuart Walker, Neil McAuslane, Lawrence Liberti, et al.
Therapeutic Innovation & Regulatory Science
|
July 4, 2020
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
Céline Rodier, Magda Bujar, Neil McAuslane, et al.
Clinical Therapeutics
|
April 22, 2021
Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
Magda Bujar, Sara Ferragu, Neil McAuslane, et al.
Frontiers in Pharmacology
|
January 4, 2021
Companies' Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study
Ting Wang, Neil McAuslane, Lawrence Liberti, et al.
International Journal of Technology Assessment in Health Care
|
September 8, 2020
Benchmarking health technology assessment agencies-methodological challenges and recommendations
Ting Wang, Iga Lipska, Neil McAuslane, et al.
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Search research articles
Search
Showing results (11-20 of 29) with videos related to
Sort By:
Page
of 3
Journal of Pharmaceutical Policy and Practice
|
September 17, 2020
An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017-2018 using the OpERA methodology
Lawrence Liberti, Rian Marie Extavour, Prisha Patel, et al.
BMJ Open
|
November 28, 2019
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
Thomas Christian Kühler, Magda Bujar, Neil McAuslane, et al.
Therapeutic Innovation & Regulatory Science
|
September 21, 2018
An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency
Petra Dörr, Alison Wadworth, Tina Wang, et al.
Therapeutic Innovation & Regulatory Science
|
February 3, 2020
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways
Lawrence Liberti, Neil McAuslane, Pieter Stolk, et al.
Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|
June 19, 2018
Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions
Ting Wang, Neil McAuslane, Lawrence Liberti, et al.
Therapeutic Innovation & Regulatory Science
|
September 18, 2018
A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
Stuart Walker, Neil McAuslane, Lawrence Liberti, et al.
Therapeutic Innovation & Regulatory Science
|
July 4, 2020
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
Céline Rodier, Magda Bujar, Neil McAuslane, et al.
Clinical Therapeutics
|
April 22, 2021
Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
Magda Bujar, Sara Ferragu, Neil McAuslane, et al.
Frontiers in Pharmacology
|
January 4, 2021
Companies' Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study
Ting Wang, Neil McAuslane, Lawrence Liberti, et al.
International Journal of Technology Assessment in Health Care
|
September 8, 2020
Benchmarking health technology assessment agencies-methodological challenges and recommendations
Ting Wang, Iga Lipska, Neil McAuslane, et al.
Page
of 3