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市場調查報告書

藥品・醫療儀器法規相關業務

Pharma and Medical Device Regulatory Affairs

出版商	Cutting Edge Information
出版日期	2010年02月	商品編碼	114353
內容資訊	英文 124 Pages
價格	US $ 7695 PDF by E-mail (Single User License) US $ 23995 PDF by E-mail (Multi User License)

簡介
目錄
相關商品

藥品・醫療儀器法規相關業務 是由出版商Cutting Edge Information在2010年02月所出版的。這份英文市場調查報告書包含124 Pages 價格從美金7695起跳。

簡介

本研究報告針對藥品・醫療儀器的法規相關業務進行分析，分別檢討產品開發團隊合作關係、與當局的連絡與社內流程、人員配置與預算、外包等項目，內容摘記如下。

實施概要

產品開發與法規相關業務的整合

社内流程與產品團隊的互動
法規相關業務結構
法規情報

與法規當局的連絡

法規相關業務與目前環境
有效的與法規當局連絡（製藥公司）
有效的與法規當局連絡（醫療儀器製造商）

法規相關業務人員與預算

人員
預算
外包

圖表

Figure 1.3: Regulatory Affairs Structure
Figure 1.4: Breakdown of Regulatory Affairs Structure by Company Type
Figure 1.5: Reporting Relationships
Figure 1.6: Breakdown of Reporting Relationships by Company Type
Figure 1.7: Position that Heads Regulatory Affairs
Figure 1.8: Responsibility Allocation for Regulatory Affairs Groups
Figure 1.9: Company 25 Structure (Large Pharma)
Figure 1.10: Company 55 Structure (Mid to Small Sized Pharma)
Figure 1.11: Company 30 Structure (Medical Devices)
Figure 1.12: Company 41 Structure (Medical Devices)

Regulatory Intelligence

Figure 1.13: Company 54 Regulatory Intelligence Structure
Figure 1.14: Intersection of Regulatory Intelligence' s Functions

Communicating with Regulatory Agencies

Regulatory Affairs and the Current Environment

Figure 2.1: Change in Regulatory Timelines Over the Past Three Years
Figure 2.2: Reasons for Lengthening Time lines Over the Past Three Years
Figure 2.3: Factors Having the Greatest Impact on Companies' Regulatory Affairs Over the Past Three Years
Figure 2.4: Factors Having the Greatest Impact on Large Companies' Regulatory Affairs Over the Past Three Years
Figure 2.5: Factors Having the Greatest Impact on Mid-size Companies' Regulatory Affairs Over the Past Three Years
Figure 2.6: Factors Having the Greatest Impact on Small Companies' Regulatory Affairs Over the Past Three Years
Figure 2.7: Factors Having the Greatest Impact on Biotech Companies' Regulatory Affairs over the Past Three Years
Figure 2.8: Factors Having the Greatest Impact on Medical Device Companies' Regulatory Affairs Over the Past Three Years
Figure 2.9: Frequency of Contact with Regulatory Agencies by Company Type

Regulatory Affairs Staffing and Budgets

Regulatory Affairs Staffing

Figure 3.1: Percentage of Companies that Outsource Some Portion of Regulatory Affairs Work
Figure 3.2: Change in Regulatory Affairs Staffing: 2007 to 2010
Figure 3.3: Average increase in FTEs by Company Type: 2007 to 2010
Figure 3.4: Average Number of FTEs Dedicated to Regulatory Affairs by Company Type
Figure 3.5: Average FTEs per Regulatory Affairs Position by Company Type
Figure 3.6: Differences in Drug and Device Regulatory Systems
Figure 3.7: Number of FTEs Dedicated to Regulatory Affairs at Large Pharmaceutical Companies
Figure 3.8: Number of FTEs Dedicated to Regulatory Affairs at Mid-size Pharmaceutical Companies
Figure 3.9: Number of FTEs Dedicated to Regulatory Affairs at Small Pharmaceutical Companies
Figure 3.1O: Number of FTEs Dedicated to Regulatory Affairs at Mid to Large Biotechnology Companies
Figure 3.11: Number of FTEs Dedicated to Regulatory Affairs at Small Biotechnology Companies
Figure 3.12: Number of FTEs Dedicated to Regulatory Affairs at Medical Device Companies

Regulatory Affairs Budgets

Figure 3.13: Percentage of Companies' Regulatory Affairs Departments that Maintain a Dedicated Budget
Figure 3.14: Breakdown of Departments Funding Regulatory Affairs at Companies with Non-Dedicate Budgets
Figure 3.15: Average Regulatory Affairs Budget by Company Type
Figure 3.16: Participating Companies' Regulatory Affairs Department Responsibilities by Activity
Figure 3.17: Large Companies' Regulatory Affairs Budgets
Figure 3.18: Participating Large Companies' Regulatory Affairs Department Responsibilities by Activity
Figure 3.19: Mid-Size Companies' Regulatory Affairs Budgets
Figure 3.20: Participating Mid-Size Companies' Regulatory Affairs Department Responsibilities by Activity
Figure 3.21: Small Companies' Regulatory Affairs Budgets
Figure 3.22: Participating Small Companies' Regulatory Affairs Department Responsibilities by Activity
Figure 3.23: Biotechnology Companies' Regulatory Affairs Budgets
Figure 3.24: Medical Device Regulatory Affairs Budgets
Figure 3.25: Participating Medical Device Companies' Regulatory Affairs Department Responsibilities by Activity
Figure 3.26: Average Budget per Activity Across All Companies
Figure 3.27: Percentage of Average Budget per Activity Across All Companies
Figure 3.28: Average Budget per Activity for Companies that Conduct the Activity
Figure 3.29: Average Percentage of Budget per Activity for Companies that Conduct the Activity
Figure 3.30: Funding Level Changes Since 2007
Figure 3.31: Funding Level Changes Since 2007 by Company Type
Figure 3.32: Comparison of Regulatory Budgets by Company Type: 2007 to 2010
Figure 3.33: Average Increase in Regulatory Affairs Budgets by Company Type: 2007 to 2010
Figure 3.34: Average Percentage Increase in Regulatory Affairs Budgets by Company Type: 2007 to 2010
Figure 3.35: Regulatory Outsourcing Percentage by Company Type
Figure 3.36: Percentage Change in Regulatory Affairs Outsourcing by Company Type
Figure 3.37: Average Regulatory Affairs Outsourcing Budget by Company Type
Figure 3.38: Average Percentage of Regulatory Affairs Budget Dedicated to Outsourcing by Company Type
Figure 3.39: Outsourcing Challenges by Category: Small Companies
Figure 3.40: Outsourcing Challenges by Category: Mid-Size Companies
Figure 3.41: Outsourcing Challenges by Category: Large Companies
Figure 3.42: Outsourcing Challenges by Category: All Pharma Companies
Figure 3.43: Outsourcing Challenges by Category: Medical Device Companies
Figure 3.44: Small Company Breakdown of Outsourced Regulatory Affairs Activity
Figure 3.45: Large Company Breakdown of Outsourced Regulatory Affairs Activity
Figure 3.46: Mid-Size Company Breakdown of Outsourced Regulatory Affairs Activity

簡介
目錄
相關商品

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藥品・醫療儀器法規相關業務

Pharma and Medical Device Regulatory Affairs

簡介