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医薬品関連法務:意見をもつ法規制団体への対応準備と戦略的課題に対応するための影響力

Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges

発行 Cutting Edge Information 商品コード 296275
出版日 ページ情報 英文 81 pages
納期: 即日から翌営業日
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医薬品関連法務:意見をもつ法規制団体への対応準備と戦略的課題に対応するための影響力 Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges
出版日: 2014年02月18日 ページ情報: 英文 81 pages
概要

世界的なコンプライアンス環境の急速な変化によって、ライフサイエンス企業は自らの法規制戦略の対応を余儀なくされています。

当レポートでは、製薬会社における法務の、法規制当局との関係構築、影響力の強化、法務マネジメントの動向などをまとめ、概略下記の構成で取り上げております。

エグゼクティブサマリー

法務の社内影響力の強化

  • 製品開発に影響を及ぼすための法的戦略の活用
  • 多機能コミュニケーションを通じた法規制戦略の導入

法規制当局との効果的関係

  • 法規制当局を理解することが有利な関係を促進する
  • 法規制当局との関係維持

法務マネジメントベンチマーク

  • 効果的な法務構造と人材
  • 法務の支出と活動の管理

図表

目次
Product Code: PH194

The rapidly fluctuating global compliance environment has placed demands on life science companies to evolve their regulatory strategies. With this study, regulatory affairs teams and strategic decision makers will be able to effectively communicate compliance priorities to clinical and marketing groups, maximize the team's influence on all aspects of product development and solidify relationships with regulatory agencies. To facilitate these objectives, the study includes detailed data showing communication processes between regulatory affairs groups and internal and external teams, as well as budgets and activities supported by these groups.

KEY QUESTIONS

ANSWERING CRITICAL QUESTIONS FOR OUR CLIENTS

The data and analysis contained in this report will help you answer many questions as you make your regulatory affairs strategy decisions. Here are some of the key questions answered in this benchmarking study:

KEY QUESTIONS ANSWERED IN THIS REPORT

  • What is the regulatory affairs team's goal?
  • What are regulatory affairs groups' roles in product development?
  • Why should companies promote communication between regulatory teams and clinical and commercial groups?
  • Why is collaboration between centralized regulatory affairs groups and local specialists important?
  • What is the ideal time for regulatory affairs teams to get involved during product development?
  • How can companies best coordinate regulatory affairs team activities?
  • Why should companies have a dedicated regulatory affairs budget?
  • Which regulatory affairs subfunction requires the most funding?
  • What kinds of challenges should companies expect when working with government agencies?
  • What can companies do to address regulatory agencies' questions and concerns?
  • Which markets most commonly present challenging compliance environments?

KEY FINDINGS

PHARMACEUTICAL REGULATORY AFFAIRS

Cutting Edge Information analysts synthesized the following principles from the full breadth and depth of this project's research. The principles are signposts to help you improve your company's regulatory affairs team's strategies and practices. While these points are not inclusive of all elements in this report, they emphasize its central and most critical concepts.

  • 1. USE REGULATORY INTELLIGENCE TO ALIGN COMPANY POLICIES WITH CURRENT REGULATIONS
  • 2. IMPLEMENT REGULATORY STRATEGY WITH CROSS-FUNCTIONAL COMMUNICATION THROUGHOUT PRODUCT DEVELOPMENT
  • 3. EDUCATE INTERNAL GROUPS ABOUT REGULATORY REQUIREMENTS AND STRATEGY TO BOOST REGULATORY TEAMS' STRATEGIC IMPACT
  • 4. COORDINATE GLOBAL SUBMISSION STRATEGY WITH LOCAL REGULATORY TEAMS
  • 5. MAINTAIN BALANCE BETWEEN EFFECTIVECENTRALIZED GROUPS AND FLEXIBLE COUNTRY-LEVEL TEAMS

KEY METRICS

CHAPTER RECOMMENDATIONS AND BENEFITS

  • Organize regulatory affairs groups around an effective central hub.
  • Balance between global and country-level teams to address both key centralized tasks and support for countries.

CHAPTER DATA

19 charts detailing regulatory affairs budget and staffing for global and country-level regulatory affairs teams:

  • Real-company diagrams of regulatory affairs structures
  • Number of FTEs within regulatory affairs in 2013, by company
  • Expected change in number of FTEs within regulatory affairs, by company
  • Sources of funding for regulatory affairs
  • Allocation of funds within regulatory affairs
  • Activities supported by regulatory affairs, by function:
  • Clinical
  • Market-oriented
  • Manufacturing

Table of Contents

Executive Summary

  • Study Methodology
  • Study Definitions
  • Regulatory Affairs Groups: Five Recommendations for Success

Strengthening Regulatory Affairs' Internal Impact

  • Using Regulatory Strategy to Impact Product Development
  • Implementing Regulatory Strategy through Cross-Functional
  • Communication

Working Effectively with Regulatory Agencies

  • Understanding Regulatory Agencies Facilitates Beneficial
  • Relationships
  • Maintaining Relationships with Regulatory Agencies

Regulatory Affairs Management Benchmarks

  • Effective Regulatory Affairs Structures and Staffing
  • Managing Regulatory Affairs Spending and Activities

CHARTS AND GRAPHICS

Executive Summary

Regulatory Affairs Groups: Five Recommendations for Success

  • Figure E.1: Importance of Regulatory Intelligence Function: Country-Level Groups
  • Figure E.2: Types of Internal Communication Challenges for Regulatory Affairs Groups

Strengthening Regulatory Affairs' Internal Impact

Using Regulatory Strategy to Impact Product Development

  • Figure 1.1 Importance of Regulatory Intelligence Function: Global Groups
  • Figure 1.2: Importance of Regulatory Intelligence Function: Country-Level Groups

Implementing Regulatory Strategy through Cross-Functional Communication

  • Figure 1.3: Number of Formal Meetings with Specific Functions per Month, by Department: Global Regulatory Affairs Groups
  • Figure 1.4: Number of Formal Meetings with Specific Functions per Month, by Company: Global Regulatory Affairs Groups
  • Figure 1.5: Number of Formal Meetings with Specific Functions per Month, by Department: Country- Level Regulatory Affairs Groups
  • Figure 1.6: Number of Formal Meetings with Specific Functions per Month, by Company: Country- Level Regulatory Affairs Groups
  • Figure 1.7: Number of Informal Meetings with Specific Functions per Month, by Department: Global Regulatory Affairs Groups
  • Figure 1.8: Number of Informal Meetings with Specific Functions per Month, by Company: Global Regulatory Affairs Groups
  • Figure 1.9: Number of Informal Meetings with Specific Functions per Month, by Department: Country-Level Regulatory Affairs Groups
  • Figure 1.10: Number of Informal Meetings with Specific Functions per Month, by Company: Country-Level Regulatory Affairs Groups
  • Figure 1.11: Level of Marketing/Commercial Executives Interacting with Regulatory Affairs Teams, by Position: Global Groups
  • Figure 1.12: Level of Clinical/R&D Executives Interacting with Regulatory Affairs Teams, by Position: Global Groups
  • Figure 1.13: Level of Medical Affairs Executives Interacting with Regulatory Affairs Teams, by Position: Global Groups
  • Figure 1.14: Level of Marketing/Commercial Executives Interacting with Regulatory Affairs Teams, by Position: Country-Level Groups
  • Figure 1.15: Level of Clinical/R&D Executives Interacting with Regulatory Affairs Teams, by Position: Country-Level Groups
  • Figure 1.16: Level of Medical Affairs Executives Interacting with Regulatory Affairs Teams, by Position: Country-Level Groups
  • Figure 1.17: Types of Internal Communication Challenges for Regulatory Affairs Groups
  • Figure 1.18: Success Ratings of Communications with Marketing/Commercial Teams: Global Regulatory Affairs Groups
  • Figure 1.19: Success Ratings of Communications with Marketing/Commercial Teams: Country-Level Regulatory Affairs Groups
  • Figure 1.20: Success Ratings of Communications with Clinical/R&D Teams: Global Regulatory Affairs Groups
  • Figure 1.21: Success Ratings of Communications with Clinical/R&D Teams: Country-Level Regulatory Affairs Groups
  • Figure 1.22: Success Ratings of Communications with Medical Affairs Teams: Global Regulatory Affairs Groups
  • Figure 1.23: Success Ratings of Communications with Medical Affairs Teams: Country-Level Regulatory Affairs Groups

Working Effectively with Regulatory Agencies

Understanding Regulatory Agencies Facilitates Beneficial

  • Relationships
  • Figure 2.1: Markets Representing the Greatest Challenge for Regulatory Affairs: Global Groups
  • Figure 2.2: Markets Representing the Greatest Challenge for Regulatory Affairs: Country-Level Groups

Maintaining Relationships with Regulatory Agencies

  • Figure 2.3: Number of Formal Meetings Between Company and Regulatory Agency for Product Launch, by Phase
  • Figure 2.4: Number of Informal Meetings Between Company and Regulatory Agency for Product Launch, by Phase
  • Figure 2.5: Number of Formal Meetings Between Company and Regulatory Agency for Product Launch, by Product
  • Figure 2.6 Number of Informal Meetings Between Company and Regulatory Agency for Product Launch, by Product

Regulatory Affairs Management Benchmarks

Effective Regulatory Affairs Structures and Staffing

  • Figure 3.1: Regulatory Affairs Structure: Company A
  • Figure 3.2: Regulatory Affairs Structure: Company B
  • Figure 3.3: Number of FTEs Within Regulatory Affairs in 2013, by Company: Global Groups
  • Figure 3.4: Expected Change in Number of FTEs Within Regulatory Affairs, by Company: Global Groups
  • Figure 3.5: Number of FTEs Within Regulatory Affairs, by Company: Country-Level Groups
  • Figure 3.6: Expected Change in Number of FTEs Within Regulatory Affairs, by Company: Country-Level Groups

Managing Regulatory Affairs Spending and Activities

  • Figure 3.7: Sources of Funding for Regulatory Affairs: Global Groups
  • Figure 3.8: Sources of Funding for Regulatory Affairs, by Company: Global Groups
  • Figure 3.9: Sources of Funding for Regulatory Affairs: Country-Level Groups
  • Figure 3.10: Sources of Funding for Regulatory Affairs, by Company: Country-Level Groups
  • Figure 3.11: Allocation of Funds Within Regulatory Affairs: All Companies
  • Figure 3.12: Allocation of Funds Within Regulatory Affairs, by Company: Global Groups
  • Figure 3.13: Allocation of Funds Within Regulatory Affairs, by Company: Country-Level Groups
  • Figure 3.14: Clinical Activities Supported by Regulatory Affairs: Global Groups
  • Figure 3.15: Market-Oriented Activities Supported by Regulatory Affairs: Global Groups
  • Figure 3.16: Manufacturing Activities Supported by Regulatory Affairs: Global Groups
  • Figure 3.17: Clinical Activities Supported by Regulatory Affairs: Country-Level Groups
  • Figure 3.18: Market-Oriented Activities Supported by Regulatory Affairs: Country-Level Groups
  • Figure 3.19: Manufacturing Activities Supported by Regulatory Affairs: Country-Level Groups
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