营销09-Canada Vigilance AR Reporting Mandarin Final 2007-07-13.pptVIP

* 加拿大警戒系统：核心软件 用于不良反应数据的收集，编码，评估和报告 工作流模块根据预先定义的标准，例如药物分类，严重程度等，将不良反应案例自动引导至评估专家/评估器 确保完全符合ICH国际不良反应报告要求，例如ICH E2B, MedDRA编码等 可选择不同配置并将提供英语和法语用户界面 * 加拿大警戒系统：信号侦测 数据挖掘和信号侦测工具 方便安全数据的分析 方便识别数据中的规律，找出构成信号的关联 用户可编写，保存和共享即时查询 提供接入FDA （FOI）数据库 - 一个用于分析和信号侦测的更大的数据仓库 统计模块包括不同算法分析，例如PRR, Bayesian, Chi-Square, Log-Likelihood * 加拿大警戒系统：电子交换 ESTRI关口模块 确保安全的电子交换，ICH E2B和M2标准安全信息的管理 计划实施该项目第二阶段 * 产品上市后系统的实施 实施分两个阶段进行： 第一阶段： 完成核心产品 – 2007年11月 第二阶段： 完成授权市场供应商（ MAH）的电子报告系统 – 2009年4月 * 谢谢！ Also ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2C(R1) – Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (PSURs) E2E – Pharmacovigilance Planning You will find on this slide the list of the 13 various risk communication documents and depending on the intended audience or who is responsible for issuance, the type of risk communication document can be different. Draft Document: Triggers for Issuance of Risk Communication Documents for Marketed Health Products for Human Use – out for public consultation. HPFB risk communications cover the scope of 4 regulated product lines 1. pharmaceuticals (including generics, OTC, prescription) 2. Biologics and genetic therapies (blood products, insulin, vaccines, future CTO regulations) 3. Natural Health Products (vitamins, herbs, homeopathics) 4. Medical Devices (band aids, surgical instruments, implanted devices like pacemaker, diagnostic equipment) Two new products were introduced in the spring of 2006 Foreign product alert- where no evidence that product marketed in Canada Information Update- position statement of HC, can let you know we are aware of and working on an issue, update on previous action. Speaking notes next slide (bar graph showing upward trend RC advisories: description of CARN, exceptions when RC is not distributed by industry (most of the time they are) In most cases the health professional communications are distributed by the industry Exce