9 October 2017 EMA/827661/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management (Rev 1) Date of coming into effect of first version 2 July 2012 Draft Revision 1* finalised by the Agency in collaboration with Member 30 June 2016 States Draft Revision...
9 October 2017 EMA/209012/2015 Guideline on good pharmacovigilance practices (GVP) Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions Draft finalised by the Agency in collaboration with Member States 30 June 2016 Draft agreed by ...
and each GVP module presents one major pharmacovigilance process. Additionally, GVP provides guidance on the conduct of pharmacovigilance for specific product types or populations in which medicines are used. These GVP considerations must be used in conjunction with the process-related guidance provided i...
Module IX signal management from strategy through detection activities, signal assessment and tracking. Read more Aggregate Safety Reporting Manage global Aggregate Safety Report schedule, generation, contributions and status across all products. Read more ...
Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.Product- or population-specific considerations The chapters on product- or population-specific considerations are currently under ...
19 The Agency has the responsibility for EudraVigilance data monitoring, signal detection and signal validation for centrally authorised vaccines and for active substances contained in several vaccines where at least one is centrally authorised (see Module IX). For vaccines authorised in more than one...
10). NO/NC wire control signal input are optional. 11). Integrated RS485 communication, infrared photocell and loop detector interface. RJ45 network, loop detector, and radar module can be added. Technical Data ModelWJDZ04SV1 (speed 3~5s adjustable) ...
需要金币:*** 金币(10金币=人民币1元) 药物警戒实践指南GVP-module-2-pharmacovigilance-system-master-file-rev-2_en.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 28 March 2017 EMA/816573/2011 Rev 2* Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigil...