3月7日,CFDI发布公告,核查中心组织对ICH官方培训材料《Q9(R1):质量风险管理》进行了翻译,现予以公开。 完整文件可前往CFDI官网查看 按照《国家药监局关于适用<Q9(R1):质量风险管理>国际人用药品注册技术协调会指导原则的公告》(2023年第114号)要求,...
1、ICH Q-IWGIntegrated Training ProgrammeJ.-L. Robert, Q-IWG Rapporteur DisclaimerThe information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop. ICH, November 2010...
ICH发布统一的Q培训材料 ImplementationofICHQ8,Q9,Q10 HowICHQ8,Q9,Q10guidelinesareworkingtogetherthroughouttheproductlifecycle InternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse ICHQualityImplementationWorkingGroup-IntegratedImplementationTrainingWorkshop HowICHQ8,Q9,Q10...
尽了个人最大的能力和努力,却还是换来了这样一个结果,伤心失望之余,多少还对自己有些“怒其不争”吧!由于此次主要倒在了起始物料的质量控制上,故痛下决心,又恶补了一把ICH Q11及其Q&A部分,恰好发现ICHQ11工作组于18年5月发布了一份关于Q&A部分的培训材料,便试着给翻译了,分享给各位伙伴。 先谈几点关于这次...
ich发布统一的q8 q9 q10培训材料.ppt,Disclaimer;Outline;Workshop Goals and Objectives;Nov 2005 Nov 2008;Pharmaceutical Development - Q8(R2);Q8(R2) - Example QbD Approach; Quality Risk Management – Q9;Quality Risk Management Process - Q9;Pharmaceutical Qua
ICH:20yearsprocess(1)•Startin1990(Brussels)•ObjectiveofICH:TechnicalandscientificharmonisationbetweenJapan,EuropeandUSA.•Scope:Newchemicalentitiesandbiotechnologyderivedproducts •Sponsors:-Regulators:EU,FDA,MHLW-Industry:EFPIA,JPMA,PhRMA •Observers:-EFTA,HealthCanada,WHO •SteeringCommittee ©ICH,...
Implementation of ICH Q8, Q9, Q10 How ICH Q8, Q9, Q10 guidelines are working together throughout the product life cycle International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Quality Implementation Working Group - Integrated Implementation...
ICH发布统一的Q8Q9Q10培训材料
0/0 收藏人数: 0 评论次数: 0 文档热度: 文档分类: 待分类 DisclaimerTheinformationwithinthispresentationisbasedontheICHQ-IWGmembersexpertiseandexperience,andrepresentstheviewsoftheICHQ-IWGmembersforthepurposesofatrainingworkshop.Outline•WorkshopGoalsandObjectives•ICHQ8,Q9&Q10•Howtheguidelinesareworkingto...
ich发布统一的qqq培训材料ppt学习教案 ICH,November2010DisclaimerDisclaimerinformationwithininformationwithinICHQ--IWGmembersIWGmembersexpertiseICHQ--IWGmembersIWGmemberstrainingworkshop.purposestrainingworkshop.ICH,November2010OutlineOutlineWorkshopGoalsObjectivesWorkshopGoalsICHQ8,Q9Q10ICHQ8,Q9workingHowworkingtogetherthr...