The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions

door Bujar, Magdalena, McAuslane, Neil, Liberti, Lawrence
Gepubliceerd in Pharmaceut Med (2021)

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

door Bujar, Magdalena, McAuslane, Neil, Walker, Stuart, Salek, Sam
Gepubliceerd in Front Pharmacol (2019)

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

door Bujar, Magdalena, McAuslane, Neil, Walker, Stuart R., Salek, Sam
Gepubliceerd in Front Pharmacol (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 pub...

door Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence
Gepubliceerd in BMJ Open (2019)

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

door Liberti, Lawrence, Extavour, Rian Marie, Patel, Prisha, McAuslane, Neil
Gepubliceerd in J Pharm Policy Pract (2020)

Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation

door Bujar, Magdalena, McAuslane, Neil, Connelly, Patricia, Walker, Stuart R.
Gepubliceerd in Ther Innov Regul Sci (2020)

Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice

door Rodier, Céline, Bujar, Magda, McAuslane, Neil, Patel, Prisha, Liberti, Lawrence
Gepubliceerd in Ther Innov Regul Sci (2020)

Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

door Keyter, Andrea, Salek, Sam, McAuslane, Neil, Banoo, Shabir, Azatyan, Samvel, Walker, Stuart
Gepubliceerd in Ther Innov Regul Sci (2020)

Companies’ Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study

door Wang, Ting, McAuslane, Neil, Liberti, Lawrence, Gardarsdottir, Helga, Goettsch, Wim, Leufkens, Hubert
Gepubliceerd in Front Pharmacol (2020)

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

door Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Gepubliceerd in Front Pharmacol (2017)

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

door Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md., Patel, Prisha
Gepubliceerd in Ther Innov Regul Sci (2020)

Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

door Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md., Patel, Prisha
Gepubliceerd in Ther Innov Regul Sci (2020)

A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016

door Patel, Prisha, Cerqueira, Daniela Marreco, Santos, Gustavo Mendes Lima, de Lima Soares, Renata, Sousa, Varley Dias, Liberti, Lawrence, McAuslane, Neil
Gepubliceerd in Ther Innov Regul Sci (2020)