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市場調查報告書

藥物安全檢測 (醫藥品安全性監視) :信號檢測、病例管理的責任與新的醫藥品安全法規的協調

Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations

出版商 Cutting Edge Information 商品編碼 279389
出版日期 內容資訊 英文 348 Pages
商品交期: 最快1-2個工作天內
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藥物安全檢測 (醫藥品安全性監視) :信號檢測、病例管理的責任與新的醫藥品安全法規的協調 Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations
出版日期: 2016年09月22日 內容資訊: 英文 348 Pages
簡介

本報告提供藥物安全檢測的最新趨勢相關調查,提示成功的重要建議。

摘要整理

識別最適合的醫藥品安全性預算,活動成本及外包的實行

結構設計及人員配置與產品主導的醫藥品安全性活動層級的調整

為了支援藥物安全檢測活動,利用內部資料庫及主題的專門知識

為了使之進步信號檢測的內部專門技術的利用

產業必要條件的不利事件報告,案例管理及文獻搜尋的調整

案例管理簡介

醫藥品安全性:成功的主要建議

關於本調查

圖表

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: PH225

Life science companies enact a number of pre- and post-marketing activities in the interests of drug safety, including:

  • Completing regulatory submissions
  • Processing incoming adverse and serious adverse event cases (AEs and SAEs)
  • Refining signal detection thresholds

The extent and depth of dialogue between teams that handle pharmacovigilance prior to and post product launch depends heavily upon the strength of companies' existing communication channels. Ideally, life science teams will establish a network that enables two-way conversations between teams supporting investigational and marketed products. Using this structure, post-marketing teams can relay safety findings to teams on the investigational side. This information will help these investigational product teams further research any newly identified pharmacovigilance concerns.

When it comes to pharmacovigilance, life science teams benefit heavily from understanding the associated regulatory climate. Since 2010, regulatory guidance has resolved some pervading issues related to drug safety processes. For example, interviewed executives emphasized that life science teams have largely grown more familiar with the requirements of a European risk management plan (RMP). Despite this progress, other challenges remain. In some cases, document requirements associated with RMP documents may lead to high - and potentially redundant - document volume. Additionally, teams may also be uncertain as to expected protocols and timelines surrounding company-provided RMP updates.

In the US, risk evaluation and mitigation strategies (REMS) guidance has resolved some of the previous confusion surrounding the Food and Drug Administration's (FDA) requirements. Since 2010, the FDA has also shifted its focus to products that require either a formal mitigation process or an escalated communication strategy. Consequently, the FDA may release some products from their respective REMS programs. However, products that require elements to assure safe use (ETASUs) or a communication plan will continue to require a REMS. For reference, communication plans may exist between either pharma and product consumers or pharma and healthcare practitioners.

Despite progress in the pharmacovigilance space, both achieving label approval and resolving regional differences in label interpretations continue to pose challenges for life science teams. For one Top 50 pharmaceutical executive, the decentralization of Asian markets renders these markets among the more difficult in which to secure labeling approval.

By comparison, mutual recognition makes label approval processes easier for companies operating within multiple European markets. Additionally, the close alignment between the European Medicines Agency (EMA) and the FDA regulations also makes the US fairly user-friendly for life science teams operating in both regions. More convenient still for companies seeking label approval, Latin American and Canadian regulatory bodies tend to require similar materials as the FDA. If companies' materials are accepted by the FDA, they are also likely to be accepted by Latin American and Canadian regulators.

Even so, other markets - from Eastern Europe, to central Africa - remain fairly undefined. Consequently, preparing for label approval in these regions can be more complicated.

Ensuring that approved labels remain consistent across each region in which products are approved may be equally - if not more - challenging for industry teams. Regulatory authorities may not dramatically diverge in their risk interpretations. However, the differences are sufficient to complicate life science companies' labeling processes. One CRO has worked with multiple companies for which consistent labeling is difficult. Essentially, having slightly different risk portfolios from region to region is not a favorable situation. Asymmetrical labels can make characterizing global product risk more difficult. In a worst-case scenario, differing risk interpretations can vastly complicate pharmacovigilance activities - particularly for life science teams with RMPs, REMS or a combination of both in place.

To ensure label harmonization across each of their drug safety teams, life science companies undertake multiple approaches. Top 50 Company A leverages a globally developed risk management plan template. This template includes a mixture of core company safety information and key data from aggregate safety documents such as periodic benefit-risk evaluation reports (PBRERs). Company A uses this template to highlight the most important elements of each of its product's risk-benefit profiles. During negotiations with local regulators, concepts discussed in Company A's template take precedence over any elements that country-, regional- or global-level teams may identify. Consequently, Company A's template helps to ensure that its most important safety materials receive label inclusion from country to country.

Other teams circumvent potential labelling challenges by communicating with regulatory bodies and researching associated legislation early. Companies seeking dual submission may describe what approved labels in one market look like to regulators in others. For example, ready access to a company's FDA-approved label may make it easier for the EMA to approve a complementary label in Europe.

One CRO recommends researching market-specific regulations as soon as possible. For example, life science companies with primary operations in the US may be unfamiliar with European requirements pertaining to qualified persons for pharmacovigilance (QPPVs) and their scope of responsibilities. Familiarizing themselves with applicable QPPV requirements will help companies comfortably establish this vital staffing representation in Europe. Researching associated regulations will also help life science teams identify the EU member states that will accept a QPPV - provided he or she resides in Europe - versus member states that require QPPVs to reside locally.

Unsurprisingly, new regulatory guidance will continue to shape the levels of harmonization expressed between various drug safety markets. Over the years, the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) has continued its efforts to improve drug identification and safety reporting practices within the life science industry. Most recently, the ICH has adjusted its existing identification of medicinal products (IDMP) guidelines and provided a separate update to its existing case reporting standards.

Preparing for upcoming regulatory changes may require some life science teams to rethink their pharmacovigilance practices. Specifically, teams might refine their drug safety standard operating procedures (SOPs) to focus on how to achieve consistent, standardized pharmacovigilance activities. As part of their SOP modifications, teams may also leverage technologies to develop organization-wide drug safety education. One drug safety vendor likens successful training programs to the flight simulators that pilots-in-training use. Essentially, any drug safety training that companies provide will need to equip FTEs with real-world, strategic applications - not just theoretical expertise.

The majority of surveyed teams (59%) leverage online channels, including social media, in drug safety monitoring. However, the frequency of teams' monitoring varies (Figure E.3). Among surveyed teams that do monitor online channels for adverse events, the majority perform daily monitoring (60%); this percentage includes all surveyed country-level drug safety groups. Global groups comprise the remaining 40% - which are evenly divided between monitoring weekly and maintaining no formal monitoring schedule.

Figure E.3:
Frequency of Online Channel Monitoring Activities, by Team Type

Table of Contents

  • Executive Summary
  • Drug Safety: Key Recommendations for Success
  • About This Report
  • Identify Best-Fit Drug Safety Budgets, Activity Costs and Outsourcing Practices
  • Standalone Drug Safety Teams Contribute to the Majority Of Drug Safety Budgets
  • Drug Safety Budget Allocated to Specific Activities
  • Drug Safety Outsourcing: Influencing Factors and Activity Costs Outsourced
  • Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels
  • Coordinate Strategy and Encourage Communication with Drug Safety Structures
  • Balance Multiple Functions' Expertise within Global and Country-Level Drug Safety Teams
  • Determine Responsibilities Before Allocating Pharmacovigilance Staffing
  • Implement and Improve Electronic Databases to Expand Pharmacovigilance Capabilities
  • Additional Drug Safety Tables
  • Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities
  • Calling on Cross-Functional Groups to Support General Pharmacovigilance Activities
  • Harnessing Internal Expertise to Advance Signal Detection
  • Crafting Risk Evaluation and Mitigation Strategies and Risk Management Plans
  • Reconciling Adverse Event Reporting, Case Management and Literature Searches with Industry Requirements
  • Quantifying Adverse Event Reporting Sources
  • Adverse Event Reporting Outlook: There's Still Room for Improvement
  • Prevent Late Cases With Robust Clinical and Post-Marketed Case Management Strategies
  • Anticipate Case Management Loads to Reflect the Number of Supported Products
  • Quantifying Data Sources and Assessing Regulations' Impact on Existing Case Management and Literature Searching Processes
  • Case Management Profiles
  • Executive Summary
  • Drug Safety: Key Recommendations for Success
  • Figure E.1: 2015 Case Management Metrics
  • Figure E.2: Average Ratings of Outsourcing Factor Importance
  • Figure E.3: Frequency of Online Channel Monitoring Activities, by Team Type
  • Figure E.4: Percentage of Functions Involved in Specific Drug Safety Activities: Drug Safety Training
  • Figure E.5: Percentage of Functions Involved in Specific Drug Safety Activities: Risk Mitigation Strategy
  • About this Report
  • Table E.1: General Team Information (1)
  • Table E.2: General Team Information (2)
  • Table E.3: General Team Information (3)
  • Table E.4: General Team Information (4)
  • Table E.5: Country-Level Team Information
  • Identify Best-Fit Drug Safety Budgets, Activity Costs and Outsourcing Practices
  • Standalone Drug Safety Teams Contribute to the Majority of Drug Safety Budgets
  • Figure 1.1: Total Drug Safety Budget, by Year: Global Teams (Top 20 and Top 50 Companies)
  • Figure 1.2: Total Drug Safety Budget, by Year: Global Teams (Small Pharmaceutical, Biotech and Vendors)
  • Figure 1.3: Average Percentage of Drug Safety Budget Contributed by Function: Global Teams
  • Figure 1.4: Percentage of Drug Safety Funding Provided by Function: Global Teams
  • Figure 1.5: Monetary Value of Funding Provided by Function: Global Teams (2014), Upper-Level Budgets
  • Figure 1.6: Monetary Value of Funding Provided by Function: Global Teams (2015), Upper-Level Budgets
  • Figure 1.7: Monetary Value of Funding Provided by Function: Global Teams (2016), Upper-Level Budgets
  • Figure 1.8: Monetary Value of Funding Provided by Function: Global Teams (2014), Mid-Level Budgets
  • Figure 1.9: Monetary Value of Funding Provided by Function: Global Teams (2015), Mid-Level Budgets
  • Figure 1.10: Monetary Value of Funding Provided by Function: Global Teams (2016), Mid-Level Budgets
  • Figure 1.11: Monetary Value of Funding Provided by Function: Global Teams (2014), Lower-Level Budgets
  • Figure 1.12: Monetary Value of Funding Provided by Function: Global Teams (2015), Lower-Level Budgets
  • Figure 1.13: Monetary Value of Funding Provided by Function: Global Teams (2016), Lower-Level Budgets
  • Figure 1.14: Total Drug Safety Budget, by Year: Country-Level Teams
  • Figure 1.15: Average Percentage of Drug Safety Budget Contributed by Function: Country-Level Teams
  • Figure 1.16: Percentage of Drug Safety Funding Provided by Function: Country-Level Teams
  • Figure 1.17: Monetary Value of Funding Provided by Function: Country-Level Teams (2014)
  • Figure 1.18: Monetary Value of Funding Provided by Function: Country-Level Teams (2015)
  • Figure 1.19: Monetary Value of Funding Provided by Function: Country-Level Teams (2016)
  • Drug Safety Budget Allocated to specific Activities
  • Figure 1.20: Average Percentage of 2015 Drug Safety Budget Dedicated to Specific Activities: Global Teams
  • Figure 1.21: Average Percentage of 2015 Drug Safety Budget Dedicated to Specific Activities: Country-Level Teams
  • Figure 1.22: Percentage of Drug Safety Budget Dedicated to Safety and Technology, by Year: Global Teams
  • Figure 1.23: Percentage of Drug Safety Budget Dedicated to Safety and Technology, by Year: Country-Level Teams
  • Figure 1.24: Safety and Technology Budgets, by Year
  • Figure 1.25: Percentage of Drug Safety Budget Dedicated to Case Management, by Year: Global Teams
  • Figure 1.26: Percentage of Drug Safety Budget Dedicated to Case Management, by Year: Country- Level Teams
  • Figure 1.27: Case Management Budgets, by Year
  • Figure 1.28: Percentage of Drug Safety Budget Dedicated to Aggregate Report Development, by Year: Global Teams
  • Figure 1.29: Percentage of Drug Safety Budget Dedicated to Aggregate Report Development, by Year: Country-Level Teams
  • Figure 1.30: Aggregate Report Development Budgets, by Year
  • Figure 1.31: Percentage of Drug Safety Budget Dedicated to Regulatory Submissions, by Year: Global Teams
  • Figure 1.32: Percentage of Drug Safety Budget Dedicated to Regulatory Submissions, by Year: Country-Level Teams
  • Figure 1.33: Regulatory Submissions Budgets, by Year
  • Figure 1.34: Percentage of Drug Safety Budget Dedicated to Medical Services, by Year: Global Teams
  • Figure 1.35: Percentage of Drug Safety Budget Dedicated to Medical Services, by Year: Country- Level Teams
  • Figure 1.36: Medical Services Budgets, by Year
  • Figure 1.37: Percentage of Drug Safety Budget Dedicated to Literature Services, by Year: Global Teams
  • Figure 1.38: Percentage of Drug Safety Budget Dedicated to Literature Services, by Year: Country- Level Teams
  • Figure 1.39: Literature Services Budgets, by Year
  • Figure 1.40: Percentage of Drug Safety Budget Dedicated to Signal Detection, by Year: Global Teams
  • Figure 1.41: Percentage of Drug Safety Budget Dedicated to Signal Detection, by Year: Country- Level Teams
  • Figure 1.42: Signal Detection Budgets, by Year
  • Figure 1.43: Percentage of Drug Safety Budget Dedicated to Due Diligence, by Year: Global Teams
  • Figure 1.44: Percentage of Drug Safety Budget Dedicated to Due Diligence, by Year: Country-Level Teams
  • Figure 1.45: Due Diligence Budgets, by Year
  • Figure 1.46: Percentage of Drug Safety Budget Dedicated to Project Management, by Year: Global Teams
  • Figure 1.47: Percentage of Drug Safety Budget Dedicated to Project Management, by Year: Country-Level Teams
  • Figure 1.48: Project Management Budgets, by Year
  • Figure 1.49: Percentage of Drug Safety Budget Dedicated to Risk Mitigation, by Year: Global Teams
  • Figure 1.50: Percentage of Drug Safety Budget Dedicated to Risk Mitigation, by Year: Country-Level Teams
  • Figure 1.51: Risk Mitigation Budgets, by Year
  • Figure 1.52: Percentage of Drug Safety Budget Dedicated to REMS/RMP Development, by Year: Global Teams
  • Figure 1.53: Percentage of Drug Safety Budget Dedicated to REMS/RMP Development, by Year: Country-Level Teams
  • Figure 1.54: REMS/RMP Development Budgets, by Year
  • Figure 1.55: Percentage of Drug Safety Budget Dedicated to Periodic, PSUR and ASR Development, by Year: Global Teams
  • Figure 1.56: Percentage of Drug Safety Budget Dedicated to Periodic, PSUR and ASR Development, by Year: Country-Level Teams
  • Figure 1.57: Periodic, PSUR and ASR Development Budgets, by Year
  • Figure 1.58: Percentage of Drug Safety Budget Dedicated to Regulatory Consulting, by Year: Global Teams
  • Figure 1.59: Percentage of Drug Safety Budget Dedicated to Regulatory Consulting, by Year: Country-Level Teams
  • Figure 1.60: Regulatory Consulting Budgets, by Year
  • Figure 1.61: Percentage of Drug Safety Budget Dedicated to Drug Safety Training, by Year: Global Teams
  • Figure 1.62: Percentage of Drug Safety Budget Dedicated to Drug Safety Training, by Year: Country- Level Teams
  • Figure 1.63: Drug Safety Training Budgets, by Year
  • Figure 1.64: Activity Timing Definitions
  • Figure 1.65: Company Blinding Information
  • Figure 1.66: Timing of Drug Safety Budget Allocations, by Activity (2015)
  • Drug Safety Outsourcing: Influencing Factors and Activity Costs Outsourced
  • Figure 1.67: Average Ratings of Outsourcing Factor Importance: Pre-Launch
  • Figure 1.68: Average Ratings of Outsourcing Factor Importance: Post-Launch
  • Figure 1.69: Preferred Vendor Capabilities, by Team Type
  • Figure 1.70: Percentage of Companies Outsourcing Drug Safety Activities, by Team Type
  • Figure 1.71: Percentage of Safety and Technology Costs Outsourced
  • Figure 1.72: Percentage of Aggregate Report Development Costs Outsourced
  • Figure 1.73: Percentage of Regulatory Submission Costs Outsourced
  • Figure 1.74: Percentage of Medical Services Costs Outsourced
  • Figure 1.75: Percentage of Literature Services Costs Outsourced
  • Figure 1.76: Percentage of Signal Detection Costs Outsourced
  • Figure 1.77: Percentage of Due Diligence Costs Outsourced
  • Figure 1.78: Percentage of Project Management Costs Outsourced
  • Figure 1.79: Percentage of Risk Mitigation Costs Outsourced
  • Figure 1.80: Percentage of Periodic, PSUR and ASR Development Costs Outsourced
  • Figure 1.81: Percentage of Regulatory Consulting Costs Outsourced
  • Figure 1.82: Percentage of Drug Safety Training Costs Outsourced
  • Figure 1.83: Percentage of REMS/RMP Development Costs Outsourced
  • Figure 1.84: Percentage of Case Management Costs Outsourced
  • Figure 1.85: Distribution of Case Management Responsibility: Bookend Triage
  • Figure 1.86: Distribution of Case Management Responsibility: Data Entry
  • Figure 1.87: Distribution of Case Management Responsibility: Medical Coding
  • Figure 1.88: Distribution of Case Management Responsibility: Medical Review
  • Figure 1.89: Distribution of Case Management Responsibility: Narrative Writing
  • Figure 1.90: Distribution of Case Management Responsibility: Other
  • Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels
  • Coordinate Strategy and Encourage Communication with Drug Safety Structures
  • Figure 2.1: Overall Drug Safety Decision-Making Structure, by Team Level
  • Figure 2.2: Drug Safety Decision-Making Structure, by Team Level: Global Teams
  • Figure 2.3: Drug Safety Decision-Making Structure, by Team Level: Country-Level Teams
  • Figure 2.4: Executive in Charge of Drug Safety, by Team Level
  • Figure 2.5: Executive in Charge of Drug Safety, by Team Level: Global Teams
  • Figure 2.6: Executive in Charge of Drug Safety, by Team Level: Country-Level Teams
  • Figure 2.7: Sample Executive Titles, by General Classification
  • Figure 2.8: Status of Standalone Group Dedicated to Drug Safety: All Teams
  • Figure 2.9: Age of Standalone Drug Safety Group: All Global Teams with Existing Group
  • Figure 2.10: Age of Standalone Drug Safety Group: All Country-Level Teams with Existing Group
  • Figure 2.11: Function in Charge of Drug Safety, by Team Level
  • Figure 2.12: Function in Charge of Drug Safety, by Team Level: Global Teams
  • Figure 2.13: Function in Charge of Drug Safety, by Team Level: Country-Level Teams
  • Figure 2.14: Functions Involved in Drug Safety, by Team Level
  • Figure 2.15: Functions Involved in Drug Safety, by Team Level: Global Teams
  • Figure 2.16: Functions Involved in Drug Safety, by Team Level: Country-Level Teams
  • Balance Multiple Functions' Expertise within Global and Country-Level Drug Safety Teams
  • Figure 2.17: Standalone Drug Safety Group Size: Global Teams
  • Figure 2.18: Number of Clinical FTEs Performing Drug Safety Activities: Global Teams
  • Figure 2.19: Number of Medical Affairs FTEs Performing Drug Safety Activities: Global Teams
  • Figure 2.20: Number of Regulatory FTEs Performing Drug Safety Activities: Global Teams
  • Figure 2.21: Number of Legal FTEs Performing Drug Safety Activities: Global Teams
  • Figure 2.22: Number of Compliance FTEs Performing Drug Safety Activities: Global Teams
  • Figure 2.23: Number of FTEs from Other Functions Performing Drug Safety Activities: Global Teams
  • Figure 2.24: Standalone Drug Safety Group Size: Country-Level Teams
  • Figure 2.25: Number of Clinical FTEs Performing Drug Safety Activities: Country-Level Teams
  • Figure 2.26: Number of Medical Affairs FTEs Performing Drug Safety Activities: Country-Level Teams
  • Figure 2.27: Number of Regulatory FTEs Performing Drug Safety Activities: Country-Level Teams
  • Figure 2.28: Number of Legal FTEs Performing Drug Safety Activities: Country-Level Teams
  • Figure 2.29: Number of FTEs from Other Functions Performing Drug Safety Activities: Country-Level Teams
  • Determine Responsibilities Before Allocating Pharmacovigilance Staffing
  • Figure 2.30: Number of FTEs Performing Safety and Technology Services: Global Teams
  • Figure 2.31: Number of FTEs Performing Safety and Technology Services: Country-Level Teams
  • Figure 2.32: Number of FTEs Performing Case Management: Global Teams
  • Figure 2.33: Number of FTEs Performing Case Management: Country-Level Teams
  • Table 2.1: 2013 Case Management Metrics
  • Table 2.2: 2015 Case Management Metrics
  • Figure 2.34: Number of FTEs Performing Aggregate Report Development: Global Teams
  • Figure 2.35: Number of FTEs Performing Aggregate Report Development: Country-Level Teams
  • Figure 2.36: Number of FTEs Performing Periodic, PSUR and ASR Development: Global Teams
  • Figure 2.37: Number of FTEs Performing Periodic, PSUR and ASR Development: Country-Level Teams
  • Figure 2.38: Number of FTEs Performing Regulatory Submissions: Global Teams
  • Figure 2.39: Number of FTEs Performing Regulatory Submissions: Country-Level Teams
  • Figure 2.40: Number of FTEs Performing Medical Services: Global Teams
  • Figure 2.41: Number of FTEs Performing Medical Services: Country-Level Teams
  • Figure 2.42: Number of FTEs Performing Literature Services: Global Teams
  • Figure 2.43: Number of FTEs Performing Literature Services: Country-Level Teams
  • Figure 2.44: Number of FTEs Performing Signal Detection and Management: Global Teams
  • Figure 2.45: Number of FTEs Performing Signal Detection and Management: Country-Level Teams
  • Figure 2.46: Number of FTEs Performing Due Diligence Projects: Global Teams
  • Figure 2.47: Number of FTEs Performing Due Diligence Projects: Country-Level Teams
  • Figure 2.48: Number of FTEs Performing Project Management: Global Teams
  • Figure 2.49: Number of FTEs Performing Project Management: Country-Level Teams
  • Figure 2.50: Number of FTEs Performing Risk Mitigation Strategy Development: Global Teams
  • Figure 2.51: Number of FTEs Performing Risk Mitigation Strategy Development: Country-Level Teams
  • Figure 2.52: Number of FTEs Performing REMS and/or RMP Development: Global Teams
  • Figure 2.53: Number of FTEs Performing US, EU and/or Other Regulatory Consulting: Global Teams
  • Figure 2.54: Number of FTEs Performing Drug Safety Training: Global Teams
  • Figure 2.55: Number of FTEs Performing Drug Safety Training: Country-Level Teams
  • Implement and Improve Electronic Databases to Expand Pharmacovigilance Capabilities
  • Figure 2.56: Life Science Teams' Global Drug Safety Database Organizational Strategy
  • Figure 2.57: Life Science Teams' Global Drug Safety Database Positioning
  • Figure 2.58: Percentage of Database Management Responsibility Outsourced: Data Storage and/or Back-Up
  • Figure 2.59: Percentage of Database Management Responsibility Outsourced: Data Migration
  • Figure 2.60: Percentage of Database Management Responsibility Outsourced: Dictionary Management
  • Table 2.3: Global and Country-Level Team Structures, by Company (1)
  • Table 2.4: Global and Country-Level Team Structures, by Company (2)
  • Additional Drug Safety Tables
  • Table 2.5: Global and Country-Level Team Structures, by Company (3)
  • Table 2.6: Global and Country-Level Team Structures, by Company (4)
  • Table 2.7: Total Product to Staffing Ratios, by Company (1)
  • Table 2.8: Total Product to Staffing Ratios, by Company (2)
  • Table 2.9: Total Product to Staffing Ratios, by Company (3)
  • Table 2.10: Total Product to Staffing Ratios, by Company (4)
  • Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities
  • Calling On Cross-Functional Groups to Support General Pharmacovigilance Activities
  • Figure 3.1: Percentage of Teams Using Selected Resources to Identify Drug Safety Information
  • Figure 3.2: Percentage of Teams Using Additional Tools to Identify Drug Safety Information
  • Figure 3.3: Percentage of Teams Conducting Drug Safety Activities, by Team Level
  • Figure 3.4: Percentage of Teams Conducting Drug Safety Activities, by Team Level: Global Teams
  • Figure 3.5: Percentage of Teams Conducting Drug Safety Activities, by Team Level: Country-Level Teams
  • Figure 3.6: Percentage of Functions Involved in Specific Drug Safety Activities: Regulatory Submissions
  • Figure 3.7: Percentage of Functions Involved in Specific Drug Safety Activities: Case Management
  • Figure 3.8: Percentage of Functions Involved in Specific Drug Safety Activities: Periodic, PSUR and ASR Development
  • Figure 3.9: Percentage of Functions Involved in Specific Drug Safety Activities: Signal Detection and Management
  • Figure 3.10: Percentage of Functions Involved in Specific Drug Safety Activities: Aggregate Report Development
  • Figure 3.11: Percentage of Functions Involved in Specific Drug Safety Activities: Literature Services
  • Figure 3.12: Percentage of Functions Involved in Specific Drug Safety Activities: Drug Safety Training
  • Figure 3.13: Percentage of Functions Involved in Specific Drug Safety Activities: REMS/ RMP Development
  • Figure 3.14: Percentage of Functions Involved in Specific Drug Safety Activities: Medical Services
  • Figure 3.15: Percentage of Functions Involved in Specific Drug Safety Activities: Risk Mitigation Strategy
  • Figure 3.16: Percentage of Functions Involved in Specific Drug Safety Activities: Project Management
  • Figure 3.17: Percentage of Functions Involved in Specific Drug Safety Activities: Safety and Technology Services
  • Figure 3.18: Percentage of Functions Involved in Specific Drug Safety Activities: Due Diligence
  • Figure 3.19: Percentage of Functions Involved in Specific Drug Safety Activities: US, EU and/or Other Regulatory Consulting
  • Figure 3.20: Regulatory Submissions: Activity Start and Peak, by Company
  • Figure 3.21: Case Management: Activity Start and Peak, by Company
  • Figure 3.22: Periodic, PSUR and ASR Development: Activity Start and Peak, by Company
  • Figure 3.23: Signal Detection and Management: Activity Start and Peak, by Company
  • Figure 3.24: Aggregate Report Development: Activity Start and Peak, by Company
  • Figure 3.25: Literature Services: Activity Start and Peak, by Company
  • Figure 3.26: REMS and/or RMP Development: Activity Start and Peak, by Company
  • Figure 3.27: Medical Services: Activity Start and Peak, by Company
  • Figure 3.28: Drug Safety Training: Activity Start and Peak, by Company
  • Figure 3.29: Risk Mitigation Strategy: Activity Start and Peak, by Company
  • Figure 3.30: Project Management: Activity Start and Peak, by Company
  • Figure 3.31: Safety and Technology: Activity Start and Peak, by Company
  • Figure 3.32: Due Diligence: Activity Start and Peak, by Company
  • Figure 3.33: US, EU and/or Other Regulatory Consulting: Activity Start and Peak, by Company
  • Harnessing Internal Expertise to Advance Signal Detection
  • Figure 3.34: Average Company-Rated Importance of Specific Data When Building a Signal Detection Threshold
  • Figure 3.35: Frequency of Risk-Threshold Parameter Adjustment, by Team Type
  • Figure 3.36: Ownership of Online Channel Adverse Event Monitoring Responsibilities, by Team Type
  • Figure 3.37: Frequency of Online Channel Monitoring Activities, by Team Type
  • Crafting Risk Evaluation and Mitigation Strategies and Risk Management Plans
  • Figure 3.38: Percentage of Teams Using Selected REMS Materials
  • Figure 3.39: Percentage of Teams Using Selected Communication Plans
  • Figure 3.40: Percentage of Teams Using Selected Post-Marketing REMS Strategies
  • Figure 3.41: REMS Timeline Comparison: Time from Receiving FDA REMS Notification Letter to REMS Submission
  • Figure 3.42: REMS Timeline Comparison: Time from REMS Submission to REMS Approval
  • Figure 3.43: Percentage of Teams Using Selected Tools to Evaluate the Success of REMS Programs
  • Reconciling Adverse Event Reporting, Case Management and Literature Searches with Industry Requirements
  • Quantifying Adverse Event Reporting Sources
  • Figure 4.1: Percentage of Total Adverse Event Reports Received, by Channel: General Telephone Number
  • Figure 4.2: Percentage of Total Adverse Event Reports Received, by Channel: Medical Information Team / Physician Hotline
  • Figure 4.3: Percentage of Total Adverse Event Reports Received, by Channel: MSL Interactions
  • Figure 4.4: Percentage of Total Adverse Event Reports Received, by Channel: Company Website
  • Figure 4.5: Percentage of Total Adverse Event Reports Received, by Channel: Company Database
  • Figure 4.6: Percentage of Total Adverse Event Reports Received, by Channel: Email
  • Figure 4.7: Percentage of Total Adverse Event Reports Received, by Channel: Social Media
  • Figure 4.8: Percentage of Total Adverse Event Reports Received, by Channel: Other
  • Figure 4.9: Percentage of Solicited Adverse Events Received, by Audience
  • Figure 4.10: Percentage of Unsolicited Adverse Events Received, by Audience
  • Figure 4.11: Breakdown of Total Adverse Events, by Audience: Physicians
  • Figure 4.12: Breakdown of Total Adverse Events, by Audience: Patients
  • Figure 4.13: Breakdown of Total Adverse Events, by Audience: Medical Information Teams
  • Figure 4.14: Breakdown of Total Adverse Events, by Audience: Sales Reps
  • Figure 4.15: Breakdown of Total Adverse Events, by Audience: Patient Assistance Programs
  • Figure 4.16: Breakdown of Total Adverse Events, by Audience: Retail Pharmacists
  • Figure 4.17: Breakdown of Total Adverse Events, by Audience: Specialty Pharmacists
  • Figure 4.18: Percentage of Solicited Serious Adverse Events Received, by Audience
  • Figure 4.19: Percentage of Unsolicited Serious Adverse Events Received, by Audience
  • Figure 4.20: Breakdown of Serious Adverse Events, by Audience: Physicians
  • Figure 4.21: Breakdown of Serious Adverse Events, by Audience: Patients
  • Figure 4.22: Breakdown of Serious Adverse Events, by Audience: Medical Information Teams
  • Figure 4.23: Breakdown of Serious Adverse Events, by Audience: Sales Reps
  • Figure 4.24: Breakdown of Serious Adverse Events, by Audience: Patient Assistance Programs
  • Figure 4.25: Breakdown of Serious Adverse Events, by Audience: Retail Pharmacists
  • Figure 4.26: Breakdown of Serious Adverse Events, by Audience: Specialty Pharmacists
  • Adverse Event Reporting Outlook: There's Still Room for Improvement
  • Figure 4.27: Desired Adverse Event Reporting Process Improvements, by Team Level
  • Prevent Late Cases With Robust Clinical and Post-Marketed Case Management Strategies
  • Anticipate Case Management Loads to Reflect The Number of Supported Products
  • Figure 4.28: Number of Investigational Products Supported in 2015, by Team
  • Figure 4.29: Number of Investigational Product Cases in 2015, by Team
  • Figure 4.30: Number of Marketed Products Supported in 2015, by Team
  • Figure 4.31: Number of Marketed Product Cases in 2015, by Team
  • Figure 4.32: Percentage of Teams Conducting Selected Case Management Activities
  • Quantifying Data Sources and Assessing Regulations' Impact on Existing Case Management and Literature Searching Processes
  • Case Management Profiles
  • Figure 5.1: Case Management Profile A: Company 1
  • Figure 5.2: Case Management Profile B: Company 39
  • Figure 5.3: Case Management Profile C: Company 30
  • Figure 5.4: Case Management Profile D: Company 27
  • Figure 5.5: Case Management Profile E: Company 6
  • Figure 5.6: Case Management Profile F: Company 12
  • Figure 5.7: Case Management Profile G: Company 9
  • Figure 5.8: Case Management Profile H: Company 10
  • Figure 5.9: Case Management Profile I: Company 11
  • Figure 5.10: Case Management Profile J: Company 32
  • Figure 5.11: Case Management Profile K: Company 33
  • Appendix A: A Comparison of Profiled Companies' Specific Product Cases with Overall 2015 Caseload
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