市場調査レポート

ファーマコビジランス(医薬品安全性監視)成功の後押し:リスク管理および有害事象レポーティング

Driving Pharmacovigilance Success: Risk Management and Adverse Event Reporting

発行 Cutting Edge Information 商品コード 279389
出版日 ページ情報 英文 128 Pages
納期: 即日から翌営業日
価格
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ファーマコビジランス(医薬品安全性監視)成功の後押し:リスク管理および有害事象レポーティング Driving Pharmacovigilance Success: Risk Management and Adverse Event Reporting
出版日: 2013年08月29日 ページ情報: 英文 128 Pages
概要

当レポートでは、ファーマコビジランスの最新動向について調査し、成功のための重要な提言を示しており、概略下記の構成でお届けいたします。

エグゼクティブサマリー

  • 調査方法
  • 定義
  • ファーマコビジランス:成功に向けた5つの重要な提言

医薬品安全性予算・アウトソース支出の管理

  • アウトソーシングは全ての医薬品安全性チームへ大きな資源を提供する

システムによって世界の医薬品安全性規制団体を成功させる

  • 集中化構造は医薬品安全性チームのプロファイル・影響を高める
  • 評価スタッフは入念な分析が必要

ファーマコビジランス活動と連携した利用可能な資源の活用

  • 企業のファーマコビジランス活動にとってのベストプラクティスの開発
  • 製品安全性の懸念を緩和するリスク管理プランの構築
  • 情報アクセシビリティを促進する医薬品安全性データベースの利用
  • 新技術の役割の理解:ファーマコビジランスチームのソーシャルメディアおよびモバイルアプリケーションの利用

図表

目次
Product Code: PH187

Abstract

Ever-changing regulatory requirements in today's increasingly global landscape reinforce companies' need for robust drug safety practices. Organizations falling short of compliance standards can incur strict penalties, from warning letters to monetary fines.

Forward-thinking companies go beyond meeting requirements to think of drug safety as a value-adding proposition. They leverage standard operating processes to ensure cohesion across global, country-level and local networks and establish accountability systems to ensure quality reports.

Elevate your drug safety efforts with team structure, staffing, outsourcing and budget benchmarks across global and country-level organizations. These data are complemented by insights on the latest trends, including teams' use of new technologies for pharmacovigilance reporting.

Optimize drug safety budgets and outsourced spending. Pharmacovigilance teams require ample resource support as product portfolios expand alongside regulatory demands. Examine detailed drug safety budget benchmarks from 2010 to 2014 projections. Finally, leverage outsourcing to keep internal teams focused on compliance and best practices.

Build a strong pharmacovigilance team - and cultivate a drug safety culture companywide. Use staffing benchmarks to right-size pharmacovigilance teams, dedicating larger headcounts and higher-skilled personnel to account for more complex product portfolios. Then, elevate drug safety awareness through stand-alone teams that sit alongside clinical and marketing. Other steps to emphasize pharmacovigilance groups' importance include providing additional training for all drug safety-facing functions.

Improve efficiency and develop best-in-class practices. Increasing data accessibility and creating standard operating procedures drive efficiency. Learn how top companies establish a global drug safety database, accountability systems and quality checks to ensure error-free reporting. Prioritize responsibilities using data on 13 key pharmacovigilance activities and see how companies use social media to enhance adverse event reporting.

Table of Contents

  • 8 Executive Summary
  • 12 Study Methodology
  • 13 Study Definitions
  • 16 Pharmacovigilance: Five Key Recommendations for Success
  • 25 Managing Drug Safety Budgets and Outsourced Spending
  • 43 Outsourcing Provides Greater Resources for All Drug Safety Teams
  • 58 Building Successful Global Drug Safety Organizations Through Structure
  • 60 Centralized Structure Elevates Drug Safety Teams' Profiles and Influence
  • 72 Evaluate Staffing Needs Through Careful Analysis
  • 86 Leveraging Available Resources to Align Pharmacovigilance Activities
  • 88 Develop Best Practices for Companies' Pharmacovigilance Activities
  • 104 Establish a Risk Management Plan to Mitigate Product Safety Concerns
  • 114 Use Drug Safety Databases to Promote Information Accessibility
  • 116 Understand The Role of New Technology: Pharmacovigilance Teams' Use of Social Media and Mobile Applications

CHARTS AND GRAPHICS

  • 8 Executive Summary
  • 15 Pharmacovigilance: Five Key Recommendations for Success
  • 16 Figure E.1: Ratio of Drug Safety FTEs Per Product
  • 19 Figure E.2: Percentage Change in Drug Safety Budgets: 2012-2013
  • 22 Figure E.3: Percentage of Pharmacovigilance Teams Reporting Global Drug Safety Database Ownership
  • 23 Figure E.4: Percentage of Pharmacovigilance Teams Using Social Media to Report Adverse Events
  • 24 Managing Drug Safety budgets and Outsourced Spending
  • 25 Figure 1.1: 2011 Total Drug Safety Budgets
  • 25 Figure 1.2: 2012 Total Drug Safety Budgets
  • 26 Figure 1.3: 2013 Total Drug Safety Budgets
  • 27 Figure 1.4: Percentage Change in Drug Safety Budgets: 2012-2013
  • 29 Figure 1.5: 2014 Drug Safety Budget Projections, by Company
  • 29 Figure 1.6: Projected Drug Safety Budget Change, by Company Type
  • 30 Figure 1.7: Drug Safety Budget Centralization: All Companies (2010)
  • 31 Figure 1.8: Drug Safety Budget Centralization: All Companies (2013)
  • 32 Figure 1.9: Pharmacovigilance Funding Sources: All Companies
  • 33 Figure 1.10: Pharmacovigilance Funding Sources: Top 20 Companies
  • 34 Figure 1.11: Pharmacovigilance Funding Sources: Top 20 Affiliates
  • 35 Figure 1.12: Pharmacovigilance Funding Sources: Top 50 Companies
  • 35 Figure 1.13: Pharmacovigilance Funding Sources: Small Companies
  • 36 Figure 1.14: Departments that Contribute to Non-Centralized Drug Safety Budgets (2010)
  • 37 Figure 1.15: Departments that Contribute to Non-Centralized Drug Safety Budgets (2013)
  • 38 Figure 1.16: Number of Investigational and Marketed Drugs Covered by Drug Safety Budgets Provided
  • 39 Figure 1.17: 2013 Drug Safety Budgets Per Product Covered
  • 40 Figure 1.18: Allocation of Drug Safety Budget Resources: All Companies (2010)
  • 41 Figure 1.19: Allocation of Drug Safety Budget Resources: All Companies (2013)
  • 42 Outsourcing Provides Greater Resources For All Drug Safety Teams
  • 43 Figure 1.20: Percentage of Companies That Outsource Pharmacovigilance Activities (2010)
  • 43 Figure 1.21: Percentage of Companies That Outsource Pharmacovigilance Activities (2013)
  • 44 Figure 1.22: Percentage of Pharmaceutical Companies That Outsource Some Portion of Their Drug Safety Budget (2010)
  • 45 Figure 1.23: Percentage of Pharmaceutical Companies That Outsource Some Portion of Their Drug Safety Budget (2013)
  • 46 Figure 1.24: Responsibility Distribution Across Companies' In-House and External Pharmacovigilance Teams
  • 47 Figure 1.25: Percentage of Drug Safety Budget Outsourced, by Company
  • 48 Figure 1.26: Distribution of Pharmacovigilance Activities, In-House Versus Outsourced: Investigational Compounds
  • 49 Figure 1.27: Distribution of Pharmacovigilance Activities, In-House Versus Outsourced: Marketed Compounds
  • 50 Figure 1.28: Pharmaceutical Companies' Use of Vendors, by Company Size (2010)
  • 50 Figure 1.29: Pharmaceutical Companies' Use of Vendors, by Company Size (2013)
  • 51 Figure 1.30: Types of Products Covered by Vendors (2010)
  • 52 Figure 1.31: Types of Products Covered by Vendors (2013)
  • 53 Figure 1.32: Most Commonly Outsourced Drug Safety Activities: All Companies (2010)
  • 53 Figure 1.33: Most Commonly Outsourced Drug Safety Activities: All Companies (2013)
  • 54 Figure 1.34: Most Commonly Outsourced Drug Safety Activities: Large Companies
  • 56 Figure 1.35: Most Commonly Outsourced Drug Safety Activities: Mid-Sized Companies
  • 56 Figure 1.36: Most Commonly Outsourced Drug Safety Activities: Small Companies
  • 57 Building Successful Global Drug Safety Organizations Through Structure
  • 59 Centralized Structure Elevates Drug Safety Teams' Profiles and Influence
  • 60 Figure 2.1: Companies' Pharmacovigilance Team Structure
  • 61 Figure 2.2: Functions Responsible for Pharmacovigilance: All Companies (2013)
  • 61 Figure 2.3: Functions Responsible for Pharmacovigilance: All Companies (2010)
  • 63 Figure 2.4: Functions Responsible for Pharmacovigilance: Top 20 Companies
  • 63 Figure 2.5: Functions Responsible for Pharmacovigilance: Top 20 Affiliates
  • 64 Figure 2.6: Functions Responsible for Pharmacovigilance: Top 50 Companies
  • 64 Figure 2.7: Functions Responsible for Pharmacovigilance: Small Companies
  • 65 Figure 2.8: Functions Responsible for Pharmacovigilance: Device Companies
  • 66 Figure 2.9: Structure of Companies' Investigational and Marketed Drug Safety Programs
  • 67 Figure 2.10: Drug Safety Organizational Structure: Company A
  • 71 Evaluate Staffing Needs Through Careful Analysis
  • 74 Figure 2.11: Global Drug Safety Team Staffing
  • 75 Figure 2.12: Global Drug Safety FTEs Per Product
  • 76 Figure 2.13: Percentage of Contract FTEs at Global Drug Safety Teams
  • 78 Table 2.14: Global Drug Safety Team FTE Distribution (2013)
  • 81 Figure 2.15: Country-Level Drug Safety Team Staffing
  • 82 Figure 2.16: Country-Level Drug Safety FTEs Per Product
  • 83 Figure 2.17: Percentage of Contract FTEs at Country-Level Drug Safety Teams
  • 84 Table 2.18: Country-Level Drug Safety Team FTE Distribution (2013)
  • 85 Leveraging Available Resources to Align Pharmacovigilance Activities
  • 87 Figure 3.1: Percentage of Companies Performing Specific Pharmacovigilance Activities: All Companies
  • 87 Develop Best Practices for Companies' Pharmacovigilance Activities
  • 88 Figure 3.2: Percentage of Companies Performing Specific Pharmacovigilance Activities: Top 20 Companies
  • 88 Figure 3.3: Percentage of Companies Performing Specific Pharmacovigilance Activities: Top 20 Affiliates
  • 89 Figure 3.4: Percentage of Companies Performing Specific Pharmac-ovigilance Activities: Top 50 Companies
  • 89 Figure 3.5: Percentage of Companies Performing Specific Pharmacovigilance Activities: Small Companies
  • 90 Figure 3.6: Stage at Which Teams Become Involved in Pharmacovigilance: All Companies
  • 91 Figure 3.7: Stage at Which Teams Become Involved in Pharmacovigilance: Top 20 Companies
  • 91 Figure 3.8: Stage at Which Teams Become Involved in Pharmacovigilance: Top 20 Affiliates
  • 92 Figure 3.9: Stage at Which Teams Become Involved in Pharmacovigilance: Top 50 Companies
  • 92 Figure 3.10: Stage at Which Teams Become Involved in Pharmacovigilance: Small Companies
  • 93 Figure 3.11: Phase Companies Begin Pharmacovigilance Activities: All Companies
  • 94 Figure 3.12: Companies' Perceived Importance of Pharmac-ovigilance Activities
  • 103 Figure 3.13: Phase Companies Begin Preparing Risk Mitigation Plans, by Company Type
  • 103 Establish a Risk Management Plan to Mitigate Product Safety Concerns
  • 104 Figure 3.14: Phase Companies Begin Preparing Risk Mitigation Plans, by Region: All Companies
  • 106 Figure 3.15: Pharmacovigilance Team's Interfunctional Relationships: Company B
  • 108 Figure 3.16: Percentage of Companies Involved in Risk Management Plans, by Company Type
  • 109 Figure 3.17: Percentage of Companies Leveraging Specific REMS Materials
  • 110 Figure 3.18: Percentage of Companies Leveraging Specific Pharmacovigilance Communication Plans
  • 111 Figure 3.19: Percentage of Companies Leveraging Specific Post-REMS Strategies
  • 112 Figure 3.20: Percentage of Companies Leveraging Proactive Safety Resources
  • 113 Figure 3.21: Percentage of Pharmacovigilance Teams Reporting Global Drug Safety Database Ownership
  • 113 Use Drug Safety Databases to Promote Information Accessibility
  • 114 Figure 3.22: Ways in Which Companies Organize Their Global Safety Databases
  • 115 Figure 3.23: Specific Channels Companies Use to Track Adverse Events
  • 115 Understand the Role of New Technology: Pharmacovigilance Teams' Use of Social Media and Mobile Applications
  • 117 Figure 3.24: Average Distribution of Companies' Adverse Event Reporting Channels
  • 117 Figure 3.25: Average Distribution of Companies' Serious Adverse Event Reporting Channels
  • 118 Figure 3.26: Percentage of Pharmacovigilance Teams That Are Active in Social Media
  • 119 Figure 3.27: Percentage of Pharmacovigilance Teams Using Social Media to Report Adverse Events
  • 120 Figure 3.28: Pharmacovigilance Teams' Preferred Social Media Adverse Event Reporting Channels
  • 120 Figure 3.29: Companies' Use of Social Media Channels, by Company Type
  • 121 Figure 3.30: Percentage of Adverse Events Received Through Social Media Channels, by Company
  • 122 Figure 3.31: Pharmacovigilance Teams' Level of Social Media Governance
  • 123 Figure 3.32: Pharmacovigilance Companies' Level of Social Media Governance, by Company Size
  • 126 Figure 3.33: Specific Tools Companies Use to Track Pharmacovigilance ROI
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