Results 211 to 220 of about 2,756,439 (291)

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women. [PDF]

Front Drug Saf Regul
Maisonneuve E, Luxi N, Bellitto C, Ciccimarra F, Raethke M, van Hunsel F, Lieber T, Mulder E, Riefolo F, Villalobos F, Thurin NH, Batel-Marques F, Morton K, O'Shaughnessy F, Cleary B, Sonderlichová S, Farcas A, Bucsa C, Favre G, Siiskonen SJ, Baud D, Sturkenboom MCJM, Trifirò G, Panchaud A.   +23 more
europepmc   +1 more source

Utilization of immune checkpoint inhibitors for the treatment of cancer in Scotland, 2018–2024: A national retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of the study is to describe the use of immune checkpoint inhibitors (ICIs) for the treatment of cancer in Scotland. Methods The retrospective observational cohort study included patients aged 18 years or older who commenced treatment with an ICI in Scotland between 1 January 2018 and 31 December 2024.
Tanja Mueller, Christine Crearie, Liya Lu, Jiafeng Pan, Fraser N. Sneden, David Martin, Amanj Kurdi, Catherine S. Thomson, Julie Clarke, Marion Bennie   +9 more
wiley   +1 more source

Acceptability of patient-centered digital vaccine safety monitoring: A Canadian Immunization Research Network study. [PDF]

Hum Vaccin Immunother
Ellis-Legault B, Wilson K, Greyson D, Shulha HP, Nilormi A, Bettinger JA.   +5 more
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Establishing an Active Vaccine Safety Surveillance System Using Large Scale Databases in Korea: Lessons and Scalable Insights for Global Application. [PDF]

J Korean Med Sci
Yoon JG, Nham E, Choi YJ, Choi MJ, Choi WS, Yoon YK, Seo YB, Hyun H, Heo JY, Lee JS, Kim CJ, Noh JY, Song JY, Cheong HJ.   +13 more
europepmc   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg, Laurens Christiaan van Rijn, Elisabeth Johanna Ruijgrok, Sinno Henricus Paulus Simons, Brigitta Carolina Maria Witjes, Jan‐Dietert Christoffer Brugma, Robert Bernard Flint   +6 more
wiley   +1 more source

Using double-negative controls to adjust for healthy-user bias in a recombinant zoster vaccine safety study. [PDF]

Am J Epidemiol
Li K, Emerman I, Cook AJ, Fireman BH, Sundaram M, Tseng HX, Weintraub ES, Yu O, Nelson JL, Shi X.   +9 more
europepmc   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Vaccine Safety

Journal of Patient Safety, 2006
openaire   +2 more sources