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Therapeutic Innovation & Regulatory Science|May 31, 2020
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its DocumentationMagdalena Bujar, Neil McAuslane, Patricia Connelly, 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 2016Thomas Christian Kühler, Magda Bujar, Neil McAuslane, et al.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 methodologyLawrence Liberti, Rian Marie Extavour, Prisha Patel, et al.Therapeutic Innovation & Regulatory Science|February 20, 2020
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and AgenciesMagdalena Bujar, Neil McAuslane, Stuart R Walker, et al.Frontiers in Pharmacology|April 27, 2017
Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the LiteratureMagdalena Bujar, Neil McAuslane, Stuart R Walker, 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|September 21, 2018
Assessing the Quality of Decision Making in the Development and Regulatory Review of Medicines: Identifying Biases and Best PracticesMagdalena Bujar, Ronan Donelan, Neil McAuslane, 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 PracticeCéline Rodier, 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 AgencyPetra 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 PathwaysLawrence Liberti, Neil McAuslane, Pieter Stolk, et al.Pageof 5