Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials: Experience from EU‐Response and conect4children consortia

V Terzić, L Levoyer, M Figarella… - British Journal of …, 2023 - Wiley Online Library
Setting‐up a high quality, compliant and efficient pharmacovigilance (PV) system in multi‐
country clinical trials can be more challenging for academic sponsors than for companies …

Development of a Safety Surveillance Plan for The Academic Medicine Sponsor Performing First in Human Cellular Therapy Clinical Trials: A Report from the …

C Adams, M Keller, JG Michlitsch… - … and cellular therapy, 2024 - Elsevier
Pharmacovigilance (PV), also known as drug safety, is the science of risk management;
involving the detection, assessment, understanding, and prevention of adverse effects …

[PDF][PDF] Pharmacovigilance study: awareness among medical students of a new medical school of Malaysia

AR Abubakar, NB Simbak, M Haque - Int J Pharm Res, 2015 - researchgate.net
Patients take medicine for the treatment of their illness and medicine is a double edge
sword, thus causes harm beside their therapeutic benefit. Pharmacovigilance program was …

[HTML][HTML] Совершенствование производственных систем фармаконадзора в условиях новых геополитических рисков

АЕ Крашенинников - … . Журнал о российском рынке лекарств и …, 2022 - cyberleninka.ru
Политические и экономические условия неизбежно влияют на разные сектора
промышленности, включая фармацевтическую. Для фармацевтической отрасли одним …

Instauración de un Servicio de Farmacovigilancia en la compañía farmacéutica Farmavisión, SA

DR Bianchini, JJM Román… - Revista Cubana de …, 2016 - revfarmacia.sld.cu
Introducción: la Farmacovigilancia es la ciencia y las actividades relacionadas con la
detección, evaluación, entendimiento y prevención de los efectos adversos o cualquier otro …

[PDF][PDF] Assessments of Harms in Clinical Trials

A Hodkinson - 2015 - core.ac.uk
Methods Reporting of harms data is assessed in a systematic review of reviews and a case
study investigating the additional value of harms data reported in clinical study reports …