WebIn Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS … WebGPSP: Good Post-Marketing Study Practice Shinsaku Kumano Author information JOURNALS FREE ACCESS 2012 Volume 140 Issue 2 Pages 81-84 DOI …
Knowledge and practice of facemask disposal among university …
WebApr 25, 2024 · The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2024, and more scientific approach has been required for PMS. The survey aims … Web14 rows · Procedures for Developing Post-marketing Study Plan (originaly published as “Procedures for Developing Post-marketing Study Plan” by PMDA in January 2024) Jun.19.2024 (abolished) Administrative Notice: Questions and Answers (Q&A) on … [2024/02/15] <MD>One Japanese Medical Device Nomenclature (JMDN) is … Differences in clinical outcomes between pre- and post-marketing clinical study … Regulatory Science - RWD WG Pharmaceuticals and Medical Devices … International Activities - RWD WG Pharmaceuticals and Medical Devices … Jp Drafts - RWD WG Pharmaceuticals and Medical Devices Agency - Pmda 16th Edition - RWD WG Pharmaceuticals and Medical Devices Agency - Pmda Post-marketing Safety Measures - RWD WG Pharmaceuticals and Medical … Jp Editions and Supplements - RWD WG Pharmaceuticals and Medical Devices … Jp FAQ - RWD WG Pharmaceuticals and Medical Devices Agency - Pmda Japanese Pharmacopoeia - RWD WG Pharmaceuticals and Medical Devices … cube root of 550
Frontiers Regulatory Approval With Real-World Data From …
WebJul 22, 2024 · The X-STAR study was a prospective, observational, 12-month study conducted from December 2015 to August 2024 in accordance with the pharmaceutical affairs law and the ministerial ordinance of Good Post-Marketing Study Practice in Japan. Ethical committee approval and written informed consent were waived for this study. WebJul 9, 2024 · The study protocol was reviewed and approved by the Japanese regulatory authority prior to study initiation, and was conducted in accordance with relevant regulations in Japan (Ministerial Ordinance on Good Post-Marketing Study Practice, Ministry of Health, Labour and Welfare Ordinance Number 171, December 20, 2004). WebAug 1, 2012 · Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing … cube root of 5627