Companies' Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study
Wang, Ting, McAuslane, Neil, Liberti, Lawrence, Gardarsdottir, Helga, Goettsch, Wim, Leufkens, Hubert
Published in Frontiers in pharmacology (03.12.2020)
Published in Frontiers in pharmacology (03.12.2020)
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Journal Article
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
Bujar, Magdalena, McAuslane, Neil, Walker, Stuart, Salek, Sam
Published in Frontiers in pharmacology (2019)
Published in Frontiers in pharmacology (2019)
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Journal Article
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
Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence
Published in BMJ open (25.11.2019)
Published in BMJ open (25.11.2019)
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Journal Article
Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile
Wang, Ting, McAuslane, Neil, Goettsch, Wim G., Leufkens, Hubert G. M., De Bruin, Marie L.
Published in Frontiers in pharmacology (18.07.2022)
Published in Frontiers in pharmacology (18.07.2022)
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Journal Article
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
Rodier, Céline, Bujar, Magda, McAuslane, Neil, Patel, Prisha, Liberti, Lawrence
Published in Therapeutic innovation & regulatory science (01.01.2021)
Published in Therapeutic innovation & regulatory science (01.01.2021)
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Journal Article
Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa
Keyter, Andrea, Salek, Sam, McAuslane, Neil, Banoo, Shabir, Azatyan, Samvel, Walker, Stuart
Published in Therapeutic innovation & regulatory science (01.09.2020)
Published in Therapeutic innovation & regulatory science (01.09.2020)
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Journal Article
An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017-2018 using the OpERA methodology
Liberti, Lawrence, Extavour, Rian Marie, Patel, Prisha, McAuslane, Neil
Published in Journal of pharmaceutical policy and practice (08.09.2020)
Published in Journal of pharmaceutical policy and practice (08.09.2020)
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Journal Article
An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology
Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md, Patel, Prisha
Published in Therapeutic innovation & regulatory science (01.09.2020)
Published in Therapeutic innovation & regulatory science (01.09.2020)
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Journal Article
Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology
Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md, Patel, Prisha
Published in Therapeutic innovation & regulatory science (01.09.2020)
Published in Therapeutic innovation & regulatory science (01.09.2020)
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Journal Article
A Comparison of the Drug Review Process at Five International Regulatory Agencies
Hirako, Mayu, McAuslane, Neil, Salek, Sam, Anderson, Carly, Walker, Stuart
Published in Drug information journal (01.05.2007)
Published in Drug information journal (01.05.2007)
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Journal Article
PD47 Associations Of Orphan Designation And Other Drug Development-Related Factors On Rollout Times And Health-Technology-Assessment Recommendations Of New-Active-Substances
Sola-Barrado, Belen, Wang, Tina, McAuslane, Neil
Published in International journal of technology assessment in health care (01.12.2022)
Published in International journal of technology assessment in health care (01.12.2022)
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Journal Article
Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures—Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions
Wang, Ting, McAuslane, Neil, Liberti, Lawrence, Leufkens, Hubert, Hövels, Anke
Published in Value in health (01.06.2018)
Published in Value in health (01.06.2018)
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Journal Article