风险管理计划的准备与实施.ppt

Carmen Bozic, MD, Biogen Idec Inc, 46th DIA meeting Carmen Bozic, MD, Biogen Idec Inc, 46th DIA meeting Carmen Bozic, MD, Biogen Idec Inc, 46th DIA meeting Carmen Bozic, MD, Biogen Idec Inc, 46th DIA meeting Carmen Bozic, MD, Biogen Idec Inc, 46th DIA meeting 内容 为何需要制定风险管理计划？ 相关法规要求 风险管理计划的准备与实施 何时？何方？如何？ 案例分享 结论 结论 RMP的目的是使与药物相关的风险减至最小，而不只是沟通。有效的RMP应该是在将病人风险减至最小的同时确保病人充分受益 制药公司通过预先准备和制定以科学为基础的RMPs，以助于在药品整个生命周期的开发管理 通过积极的风险管理，主动进行药品安全监测及实时评估益处-风险比，制药公司可以建立药品开发计划，使患者尽早应用挽救生命和提高生活质量的药物 监管部门进行核查，确保公众健康得到更好的保护 一个产品的全球RMP代表了公司的政策，但是由于各国医疗保健系统不同，不一定能适合所有国家；在准备中国的RMP时，应包括全球RMP的强制要求和本国额外的要求 谢谢 ！ BACK-UP SLIDES Phase IV Post-Marketing Phase III Phases I II Pre-clinical Development Research FIH EOPh1 EOPh2 Filing Core Safety Information Investigator Brochure Prescribing Information Target Product Profile Informed Consent REMS Request REMS Proposal Cross-functional Execution of RMP Early RMP Filing RMP Final RMP Early RMP Governance Requirements Adequate Resources Advanced Signal Detection Tools SOPs RACIs Templates Project Management Metrics Training RMP = Risk Management Plan REMS = Risk Evaluation Mitigation Strategy Ongoing Safety Data Review by Multidisciplinary Safety Teams Ongoing Signal Detection Consultation with Regulatory Authorities Proactive Risk Management Planning Emerging Best Practices for Safety Risk Management EU – RMP Template FDA REMS Template Goal REMS Elements A. Medication Guide B. Communication Plan C. Elements to assure Safe Use D. Implementation System E. Timetable for Submission of Assessments Medication Guide The product’s brand name and established (or proper) name with phonetic spellings; The most important information the patient should know about the product, including the public health concerns that created the need for the MedGuide; What type of drug or biologic the product is, and what it is indicated for; Who should not take the product (e.g., contraindications); How patients should take it; What patients shou