Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Filters

Magda Bujar

Showing results (1-10 of 10) with videos related to

Pageof 1
Sort By:
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.
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.
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.
Pharmaceutical Medicine|April 19, 2023
Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory AuthoritiesNeil McAuslane, Magda Bujar, Tariro Sithole, et al.
Frontiers in Pharmacology|April 20, 2017
FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization TimelinesLawrence Liberti, Magda Bujar, Alasdair Breckenridge, et al.
Therapeutic Innovation & Regulatory Science|October 26, 2023
An Evaluation of the Swissmedic Regulatory Framework for New Active SubstancesMagda Bujar, Simon Andreas Dalla Torre di Sanguinetto, Adem Kermad, et al.
Regulatory Toxicology and Pharmacology : RTP|March 18, 2023
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengtheningJane Mashingia, Nancy Ngum, Margareth Ndomondo-Sigonda, et al.
Frontiers in Medicine|October 9, 2025
Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizationsAgnes Dangy-Caye, Alice Mousset, Adem Kermad, et al.
Therapeutic Innovation & Regulatory Science|July 25, 2025
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting ApproachNoraisyah Mohd Sani, Siti Hidayah Kasbon, Kian Yee Yap, et al.
Clinical and Translational Science|July 6, 2023
A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug AdministrationUlrich-P Rohr, Mario Iovino, Leonie Rudofsky, et al.
Pageof 1

Showing results (1-10 of 10) with videos related to

Sort By:
Pageof 1
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.
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.
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.
Pharmaceutical Medicine|April 19, 2023
Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory AuthoritiesNeil McAuslane, Magda Bujar, Tariro Sithole, et al.
Frontiers in Pharmacology|April 20, 2017
FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization TimelinesLawrence Liberti, Magda Bujar, Alasdair Breckenridge, et al.
Therapeutic Innovation & Regulatory Science|October 26, 2023
An Evaluation of the Swissmedic Regulatory Framework for New Active SubstancesMagda Bujar, Simon Andreas Dalla Torre di Sanguinetto, Adem Kermad, et al.
Regulatory Toxicology and Pharmacology : RTP|March 18, 2023
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengtheningJane Mashingia, Nancy Ngum, Margareth Ndomondo-Sigonda, et al.
Frontiers in Medicine|October 9, 2025
Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizationsAgnes Dangy-Caye, Alice Mousset, Adem Kermad, et al.
Therapeutic Innovation & Regulatory Science|July 25, 2025
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting ApproachNoraisyah Mohd Sani, Siti Hidayah Kasbon, Kian Yee Yap, et al.
Clinical and Translational Science|July 6, 2023
A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug AdministrationUlrich-P Rohr, Mario Iovino, Leonie Rudofsky, et al.
Pageof 1