Efficacy Guidelines有效性 E1Clinical Safety for Drugs used in Long-Term Treatment(长期用药的临床安全性) E2Pharmacovigilance(药物警戒) E3Clinical Study Reports(临床研究报告) E4Dose-Response Studies(量-效关系研究) E5Ethnic Factors(种族因素) E6Good Clinical Practice(药物临床研究质量管理规范) E7Clinical ...
This ICH IG focuses on medicinal products and therapeutic biologics for human use. However, the ICH is aware of other regional applications of the messaging standard that have a wider scope, such as pharmacovigilance activities related to vaccines, herbal products, cosmetics, veterinary products or m...
CIOMS, Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V. Geneva; World Health Organization (WHO), 2001. Guidelines for Good Pharmacoepidemiology Practices (GPP), International Society for Pharmacoepidemiology,http://www.pharmacoepi.org/resources/guidelines_08027...
The extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions E1:人群暴露程度:评估非危及生命性疾病长期治疗药物的临床安全性 阶段 5 1994.10.27 有 2 2 E2A - - E2F Pharmacovigilance/ 药物警戒性 E2A: Clinical Safety Da.....
31、afety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report a36E2C(R2) -E2FE2C(R2) Q&AsQuestions & Answers: Periodic Benefit-Risk Evaluation ReportE2D Post-Approval Safety Data Management: Definitions and Standards for Expedited ReportingE2E Pharmacovigilance PlanningE2F Development Safety Update ...
Efficacy Guidelines 有效性 Clinical Safety for Drugs used in Long-Term Treatment(长期用药的临床安 E1 全性) E2 Pharmacovigilance(药物警戒) E3 Clinical Study Reports(临床研究报告) E4 Dose-Response Studies(量-效关系研究) E5 Ethnic Factors(种族因素) ...
―E‖类专题——EfficacyGuidelines―M‖类专题——MultidisciplinaryGuidelines ICH简介 •名称2015.10.23更名为：InternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse（ICH）人用药物技术要求国际协调理事会 曾用名：InternationalConferenceonHarmonisationofTechnicalRequirementsfor...
Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of ...
2E2A - E2F Pharmacovigilance/药物警戒性 E2A: Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2A: 临床安全性数据管理:快速报告的定义和标准阶段51994.10.27有 E2B(R3):Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data...
ICH和欧盟药品风险管理指南简介 ＣｈｉｎＪＣｌｉｎＰｈａｒｍａｃｏｌ７７ＶＯＩ．２５ＮＯ．２Ｍａｒ．２．００９（ＳｅｒｉａｌＮｏ．１ １８）ＩＣＨ和欧盟药品风险管理指南简介Ｓｕｍｍａｒｉｚｅｏｆｇｕｉｄｅｌｉｎｅｓｏｎ ｄｒｕｇｒｉｓｋ ｍａｎａｇｅｍｅｎｔｐｒｏｇｒａｍｓＩＣＨａｎｄ ＥＭＥＡ唐健元（...