Cover Image
市場調查報告書 - 228129


Risk Evaluation and Mitigation Strategies (REMS)

出版商 Business Insights
出版日期 內容資訊 英文 120 Pages
醫療藥物風險評估及減緩策略(REMS) Risk Evaluation and Mitigation Strategies (REMS)
出版日期: 2011年08月23日 內容資訊: 英文 120 Pages



  • 簡介
  • 風險管理方之進展
  • 歐美政府實施之管理策略
  • 上市前發現風險策略
  • 上市後風險減緩策略
  • 未來展望:利益關係人觀點


  • 免責聲明


  • 摘要
  • 簡介
  • 發現風險
  • 風險評估、分析
  • 風險資訊傳達及管理
  • 本報告概略


  • 摘要
  • 簡介
  • 風險管理方之進展
  • 資訊傳達中風險管理及最小化
    • 案例研究:cisapride(產品名:Propulsid、製藥企業:Ortho-McNeil-Janssen)
    • 案例研究:alosetron(產品名:Lotronex、製藥企業:GlaxoSmithKline)
  • 超越風險資訊傳達之策略
    • 案例研究:clozapine(產品名:Clozaril、製藥企業:Novartis)
    • 案例研究:thalidomide(產品名:Thalomid、製藥企業:Celgene)
    • 案例研究:isotretinoin(產品名:Accutane、製藥企業:Roche)
  • 結論


  • 摘要
  • FDA(美國食品和藥物管理局)具義務之風險管理活動
    • 上市後之廣告活動
    • 風險評估減緩策略
    • 給藥介紹資訊
    • 整體藥劑等級風險評估減緩策略
    • 評估減緩策略系統檢視
  • EMA(歐洲醫學協會 )從事之風險管理活動
    • 歐洲醫療藥物安全監視系統之變更點
  • 美國及歐洲風險管理活動之比較
  • 結論


  • 摘要
  • 簡介
  • 臨床前毒性實驗
    • 計算機篩選及化學信息學
    • 體外實驗
    • 動物實驗
    • 藥劑開發前之生物標誌物
  • 初期臨床開發之技術創新
    • 預備研究:零相位
    • 藥物評價研究
  • 臨床開發前之安全監視
    • 嚴重不良事件之報告
    • 報告要件
    • 藥劑開發時之數據發現
  • 結論


  • 摘要
  • 簡介
  • 醫療藥物安全監視及數據發現
  • 許可後臨床研究:第IV階段
    • 觀察性藥劑流行病學研究
    • 描述性研究
    • 標靶臨床研究
  • 減緩風險活動
    • 減緩風險工具設計之進步
    • 評估減緩風險策略
  • 結論
  • ■未來展望:利益關係人觀點
  • 摘要
  • 簡介
  • 政府當局
    • 法規合理化
  • 製藥企業
    • 週期管理
    • 執行組織改革
    • 與法規當局交換資訊
    • CRO(首席風險官)
  • 患病者、醫師、藥劑師
    • 與利益關係人之關係
    • 資訊傳達風險
    • 資訊科學及社群媒體
  • 結論


  • 調查方式
  • 縮寫
  • 專業用語
  • 參考資料



This report takes an in-depth look at risk detection, analysis, and mitigation for novel and marketed medicinal products. It investigates the way in which drug risk management has changed over time and provides case studies of drugs that have been pivotal in changing regulations. The future outlook from the perspective of different stakeholders also presented.


  • Evaluate the ways in which drug safety regulation has evolved and why.
  • Assess areas of contention or change in current drug safety regulation in the EU and US.
  • Identify key consortia that are working to establish improved methods of predicting drug safety in preclinical development.
  • Evaluate the future of drug safety and REMS from the perspective of different stakeholders in the system.
  • Understand who is responsible for ensuring the safety of drugs at different parts of the lifecycle.


Current regulatory guidance outlines methods for planning risk communication and minimization strategies that might be imposed in cases where drugs have important benefits but are also associated with risks for patients. This represents an evolution brought about by advances in science and technology.

Risk evaluation and mitigation strategies (REMS) imposed by the FDA have been the subject of criticism since their introduction in 2007. The FDA are listening to stakeholders and current form of REMS is likely to change.

A wealth of research is ongoing within the pharma industry and academia to understand the potential risks associated with a new drug before it reaches the marketplace. A great deal of the work being undertaken focuses on preclinical, predictive models of drug safety and consortia are particularly important in this area.


  • What are the different activities required to investigate and manage drug safety?
  • What are companies and regulators doing to improve their ability to develop and approve safe drugs?
  • Are current regulations likely to change and why?
  • What are companies and regulators doing to improve their ability to safeguard public health by minimizing the risks posed by marketed drugs?
  • How are other stakeholders influencing the situation?

Table of Contents

Executive Summary

  • Introduction
  • Evolution of risk management practices
  • Strategies for risk management imposed by EU and US regulators
  • Pre-marketing strategies for detecting risk
  • Post-marketing strategies for minimizing risk
  • Future outlook: stakeholder perspectives

About the authors

  • Disclaimer


  • Summary
  • Introduction
  • Detecting risks
  • Analysis and evaluation of risk
  • Management of risk, including risk communication
  • Report outline

Evolution of risk management practices

  • Summary
  • Introduction
  • Evolution of risk management strategies
  • Communication to manage and minimize risk
    • Case study: cisapride (Propulsid; Ortho-McNeil-Janssen)
    • Case study: alosetron (Lotronex; GlaxoSmithKline)
  • Beyond risk communication
    • Case study: clozapine (Clozaril; Novartis)
    • Case study: thalidomide (Thalomid; Celgene)
    • Case study: isotretinoin (Accutane; Roche)
  • Conclusions

Strategies for risk management imposed by EU and US regulators

  • Summary
  • Risk management activities required by the FDA
    • Enforcing post-marketing commitments
    • Risk Evaluation and Mitigation Strategies
    • Medication guides
    • Class-wide REMS
    • Review of the REMS system
  • Risk management activities imposed by the EMA
    • Changes to the EU's pharmacovigilance system
  • Comparison of risk management activities in the US and the EU
  • Conclusions

Pre-marketing strategies for detecting risk

  • Summary
  • Introduction
  • Innovation in preclinical toxicity testing
    • In silico screening and chemoinformatics
    • In vitro testing
    • Animal studies
    • Biomarkers in drug development
  • Innovation in early clinical drug development
    • Exploratory studies: Phase 0
    • Pharmacometrics
  • Monitoring safety during clinical development
    • Reporting serious adverse events
    • Reporting requirements
    • Data mining during drug development
  • Conclusions

Post-marketing strategies for minimizing risk

  • Summary
  • Introduction
  • Pharmacovigilance and data mining
  • Post-approval clinical research: Phase IV
    • Observational pharmacoepidemiological studies
    • Descriptive studies
    • Targeted clinical investigations
  • Risk minimization activities
    • Innovation in risk minimization tool design
    • Evaluating risk mitigation strategies
  • Conclusions

Future outlook: stakeholder perspectives

  • Summary
  • Introduction
  • Regulators
    • Putting risk in context
  • Pharmaceutical companies
    • Lifecycle management
    • Implementing organizational change
    • Communicating with regulators
    • CROs
  • Patients, physicians and pharmacists
    • Stakeholder involvement
    • Communicating risk
    • Informatics and social media
  • Conclusions


  • Research methodology
  • Abbreviations
  • Glossary
  • References
Back to Top