Publications by authors named "Judith MacDonald"

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Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe-An EFPIA View.
Iain Todd, Ruediger Faust, Esteban Herrero-Martinez, Nasir Hussain, Adam Kawinski, Judith Macdonald

Clin Ther· November 2023

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Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.
Prisha Patel, Judith C Macdonald, Jayanthi Boobalan, Matthew Marsden, Ruben Rizzi

Front Med (Lausanne)· November 2023

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Walking the talk in digital transformation of regulatory review.
Ramy Khalil, Judith C Macdonald, Andrew Gustafson, Lina Aljuburi, Fabio Bisordi

Front Med (Lausanne)· July 2023

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Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US.
Gentaro Tajima, Seoan Huh, Natalie Anne Schmidt, Judith C Macdonald, Tobias Fleischmann

Mol Ther Methods Clin Dev· September 2022

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Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health-an EFPIA View.
Esteban Herrero-Martinez, Nasir Hussain, Nadege Le Roux, Judith MacDonald, Mark Mayer

Clin Ther· January 2022

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Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution?
Judith C Macdonald, David C Isom, Daniel D Evans, Katy J Page

Front Med (Lausanne)· May 2021

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Strengthening regulatory systems for medicines in a changed world: where do we go from here?
Julie O'Brien, Rebecca Lumsden, Judith Macdonald

BMJ Glob Health· January 2021

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Domestic Risk Factors for Atopic and non-Atopic Asthma in First Nations Children Living in Saskatchewan, Canada.
Donna C Rennie, Chandima P Karunanayake, Josh A Lawson, Shelley Kirychuk, Kathleen McMullin, Judith MacDonald

Children (Basel)· April 2020

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Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally.
Julie O'Brien, Rebecca Sarah Lumsden, Dellarika Hedwig Diehl, Judith Catherine Macdonald

Ther Innov Regul Sci· March 2020

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Determinants of excessive daytime sleepiness in two First Nation communities.
Ina van der Spuy, Chandima P Karunanayake, James A Dosman, Kathleen McMullin, Gaungming Zhao, Judith MacDonald

BMC Pulm Med· December 2017

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Regulatory considerations in oncologic biosimilar drug development.
Judith C Macdonald, Helen Hartman, Ira A Jacobs

MAbs· March 2016

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Clinical considerations for the development of biosimilars in oncology.
Mark A Socinski, Giuseppe Curigliano, Ira Jacobs, Barry Gumbiner, Judith MacDonald

MAbs· November 2015

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