Results 81 to 90 of about 31,766 (260)

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

Impact of the pancreatic enzyme replacement therapy (PERT) shortage on prescribing in England: Analysis of national data

British Journal of Clinical Pharmacology, EarlyView.
Aim Pancreatic enzyme replacement therapy (PERT) is essential for the management of pancreatic exocrine insufficiency. Since June 2023, the United Kingdom has been affected by a global shortage of PERT. We investigated the impact of this shortage on national prescribing trends for Creon, Nutrizym, Pancrex and Pangrol.
Teena S. Varghese, Mary E. Phillips, Louis Fisher, Helen Fitt, Adam Frampton, Christopher Wood, Agnieszka Lemanska   +6 more
wiley   +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

Estimation of Symptomatic Respiratory Syncytial Virus Infection Incidence in Adults in Multiple Countries: A Time-Series Model-Based Analysis Protocol

Infectious Diseases and Therapy
Introduction Estimating respiratory syncytial virus (RSV) burden in adults is challenging because of non-specific symptoms, infrequent standard-of-care testing, resolution of viral shedding before seeking medical care, test positivity that varies by ...
Robin Bruyndonckx, Aleksandra Polkowska-Kramek, Caihua Liang, Charles Nuttens, Thao Mai Phuong Tran, Bradford D. Gessner, Elizabeth Begier   +6 more
doaj   +1 more source

Pharmacovigilance: Scope for a dermatologist

Indian Journal of Dermatology, 2011
Pharmacovigilance is defined as the science of detection, assessment, and prevention of adverse drug reactions in humans. Under-reporting of drug reactions is the major problem and has various reasons. The WHO has initiated the program of reporting all adverse drug reactions now co-ordinated by the Uppsala Monitoring Centre in Uppsala, Sweden, with ...
Bhanu Prakash, Gurcharan Singh
openaire   +3 more sources

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke, Boitumelo Semete‐Makokotlela, Varnika Singh, Khanyisile Nkuku, Madelein Terblanche, Ezekiel T Mukanga, Nancy Ngum, Kudakwashe Dandajena, McNeil Chimus Mhango, Paulyne Wairimu, John Mwangi, Dominique Lagrave, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

Strengthening Pharmacovigilance Reporting for Withdrawal Reactions to Support Deprescribing

Clinical Pharmacology &Therapeutics, EarlyView.
Pharmacovigilance plays a crucial role in post‐marketing surveillance of medicines and relies on the spontaneous reporting of adverse drug reactions (ADRs). Discontinuation of a drug can cause clinically relevant signs and symptoms, including withdrawal reactions; however, this subset of ADRs is not fully accommodated in current pharmacovigilance ...
Zakir Khan, Frank Moriarty
wiley   +1 more source

A systematic review and pharmacovigilance analysis of the risk of agranulocytosis associated with metamizole use

Scientific Reports
Metamizole is an analgesic widely used after its introduction but later withdrawn in several countries due to the risk of agranulocytosis. Despite this, it remains frequently used worldwide.
Alessia Zinzi, Mario Gaio, Donatella Ruggiero, Consiglia Riccardi, Cecilia Cagnotta, Ciro Pentella, Annalisa Capuano, Concetta Rafaniello   +7 more
doaj   +1 more source