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市場調查報告書

醫療設備廠商的法規相關業務、遵守

Regulatory Affairs And Compliance For Medical Device Manufacturers

出版商 Cutting Edge Information 商品編碼 361715
出版日期 內容資訊 英文 88 Pages
商品交期: 最快1-2個工作天內
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醫療設備廠商的法規相關業務、遵守 Regulatory Affairs And Compliance For Medical Device Manufacturers
出版日期: 2016年06月30日 內容資訊: 英文 88 Pages
簡介

本報告提供醫療設備廠商的法規相關業務、遵守團隊結構與策略相關調查分析。

有效的法規相關業務結構、預算的建立

  • 與內部需求對應的集中性的法規相關業務的建立

強化法規相關業務的策略性影響

  • 提高法規影響的跨功能性的群組的有效利用
  • 各法規當局、計劃的導向
  • 產品案例研究:為了強化法規的參予對當局的應對

為了支撐組合需求而建立遵守

  • 遵守團隊結構與企業需求適合
  • 遵守資源降低與機能重要性的高漲的平衡

實行遵守的訓練、SOP的業界標準

  • 由於遵守訓練保證業界標準
  • 人員編制、通訊及法規情報中課題的克服
  • 遵守團隊簡介:開發有效的SOP的團隊的配合措施的焦點

圖表

目錄
Product Code: PH236

At medical device companies, compliance and regulatory affairs are often confused and sometimes intertwined functions. Both functions use regulatory intelligence to stay up-to-date on current requirements and are responsible for disseminating these regulations throughout the company. However, they serve different purposes within a company. Namely, regulatory affairs teams are concerned mainly with a product's development and lifecycle while compliance deals mostly in how personnel operate within and around the company.

The main goal of regulatory affairs is to help a product earn market authorization and keep it. To achieve their goal, regulatory affairs focuses on a product's lifecycle - including clinical trials, manufacturing, marketing and medical affairs for that product - and adjusts these developments to meet the agency's requirements. As a result, regulatory affairs budgets and staffing will often vary by the company's pipeline so that there will be a larger regulatory presence when a company is preparing to launch a product. Nonetheless, successful regulatory affairs teams will be involved throughout a product's lifecycle - not just during the submission phase. In fact, regulatory affairs can impact all stages of product development to ensure that every clinical trial, marketing campaign and other product-related activity will promote market authorization.

Compliance, on the other hand, takes a look at company functions from an outside perspective and compares them to current industry standards to help the company avoid the product recalls, expensive fines and embarrassing publicity that can result from noncompliance. If there are differences between company policies and expected industry policies, compliance teams develop internal protocols to align company practices with current good practices in the industry. Compliance teams are also responsible for training company personnel about these industry standards. Even though compliance teams can work in the background - setting protocols, auditing, training personnel - of nearly any company function, compliance teams are generally small. Because of their small size, successful compliance teams will adjust their structures and operations to deliver the greatest company impact.

USE OF THIS REPORT

This report discusses regulatory affairs and compliance teams' structures and strategies at device companies. The structure for the report is as follows:

CHAPTER 1: BUILDING EFFECTIVE REGULATORY AFFAIRS STRUCTURES AND BUDGETS

Regulatory affairs outsourcing, budget and staffing practices vary by company pipeline and preference. Nonetheless, surveyed companies structure their regulatory affairs teams in similar ways to increase the team's strategic impact.

CHAPTER 2: ENHANCING REGULATORY AFFAIRS' STRATEGIC IMPACT

Effective regulatory affairs teams will strategically impact a product throughout its lifecycle. Interfunctional meetings, agency communication and regulatory intelligence can increase regulatory affairs' influence and the chances of earning - and keeping - market approval.

CHAPTER 3: STRUCTURING COMPLIANCE TO SUPPORT PORTFOLIO DEMANDS

Compliance functions can be structured in several ways to have the greatest impact. In general, compliance teams are small with low budgets. Among surveyed companies, very few teams outsource portions of their compliance budgets, suggesting that companies benefit from housing their own compliance teams.

CHAPTER 4: IMPLEMENTING INDUSTRY STANDARDS WITH COMPLIANCE TRAINING AND SOPS

Compliance teams enforce industry standards by training employees about current codes of conducts and standard operating procedures. The amount of time spent training each FTE depends on the function and company. It also depends on whether the employee is internal, external or a new hire. Compliance teams face some challenges in staffing and company communication, however, which may hinder compliance's efforts.

Table of Contents

  • 8 Study Methodology
  • 9 Study Definitions
  • 10 Building Regulatory Affairs Team Influence Through Structure and Budget
  • 11 Structuring Centralized Regulatory Affairs Functions to Meet Internal Needs
  • 30 Enhancing Regulatory Affairs' Strategic Impact
  • 31 Leveraging Cross-functional Groups to Increase Regulatory Impact
  • 42 Navigating Different Regulatory Agencies and Timelines
  • 52 Product Case Studies: Meeting with Agencies to Enhance Regulatory Involvement
  • 59 Structuring Compliance Teams to Support Portfolio Demands
  • 60 Matching Compliance Team Structure to Company Needs
  • 65 Balancing Declining Compliance Resources with Increasing Functional Importance
  • 69 Implementing Industry Standards with Compliance Training and SOPs
  • 70 Ensuring Industry Standards with Compliance Training
  • 81 Overcoming Challenges in Staffing, Communication and Regulatory Intelligence
  • 84 Compliance Team Profiles: Focusing Team Efforts to Develop Effective SOPs
  • 8 Study Methodology
  • 9 Study Definitions
  • 10 Building Regulatory Affairs Team Influence Through Structure and Budget
  • 11 Structuring Centralized Regulatory Affairs Functions to Meet Internal Needs
  • 12 Figure 1.1: Regulatory Affairs Group Structure
  • 12 Figure 1.2: Level of Executive Leading Regulatory Affairs
  • 13 Figure 1.3: Countries/Regions for Which Regulatory Affairs Is Responsible
  • 13 Figure 1.4: Therapeutic Areas for Which Regulatory Affairs Is Responsible
  • 14 Figure 1.5: Functions that Regulatory Affairs Oversees
  • 15 Figure 1.6: Age of Regulatory Affairs Functions
  • 16 Figure 1.7: Age of Regulatory Affairs Functions, by Company
  • 17 Figure 1.8: Regulatory Affairs Budgets, by Company
  • 18 Figure 1.9: Departments that Fund Regulatory Affairs
  • 19 Figure 1.10: Percentage of Funding from Different Departments, by Company
  • 20 Figure 1.11: Percentage of Total Funding Spent on Regulatory Affairs Activities
  • 21 Figure 1.12: Time and Budget Spent on Regulatory Activities for Company 3
  • 22 Figure 1.13: Time and Budget Spent on Regulatory Activities for Company 4
  • 22 Figure 1.14: Time and Budget Spent on Regulatory Activities for Company 5
  • 23 Figure 1.15: Percentage of Companies that Outsource a Portion of Regulatory Affairs Responsibilities
  • 24 Figure 1.16: Percentage of Regulatory Affairs Budget Outsourced
  • 24 Figure 1.17: Percentage of Regulatory Budget Outsourced, by Company
  • 25 Figure 1.18: Percentage of Regulatory Affairs Work Outsourced
  • 26 Figure 1.19: Frequency of Contact with Outsourced Personnel
  • 27 Figure 1.20: Number of FTEs Within Regulatory Function, by Company
  • 28 Figure 1.21: Number of Outsourced and In-House Regulatory Affairs FTEs, by Company
  • 29 Figure 1.22: Number of FTEs Within Regulatory Function, by Company
  • 30 Enhancing Regulatory Affairs' Strategic Impact
  • 31 Leveraging Cross-Functional Groups to Increase Regulatory Impact
  • 31 Figure 2.1: Importance of a Successful Regulatory Intelligence Function
  • 32 Figure 2.2: Functions with Which Regulatory Affairs Often Interacts
  • 33 Figure 2.3: Regulatory Affairs Groups' Involvement with Marketing Activities
  • 34 Figure 2.4: Regulatory Affairs Groups' Involvement with Clinical Trials
  • 35 Figure 2.5: Regulatory Affairs Groups' Involvement in Manufacturing Activities
  • 36 Figure 2.6: Level of Regulatory Affairs Teams' Interaction with Marketing/Commercial
  • 37 Figure 2.7: Level of Regulatory Affairs Teams' Interaction with Clinical/R&D
  • 37 Figure 2.8: Level of Regulatory Affairs Teams' Interaction with Medical Affairs
  • 39 Figure 2.9: Frequency of Meetings with Marketing/Commercial per Month
  • 39 Figure 2.10: Frequency of Meetings with Clinical/R&D per Month
  • 40 Figure 2.11: Frequency of Regulatory Affairs Teams' Meetings with Medical Affairs per Month
  • 41 Figure 2.12: Regulatory Affairs Teams' Perceived Success in Communicating with Different Functions
  • 42 Figure 2.13: Which Regulatory Body Poses More Challenges?
  • 42 Navigating Different Regulatory Agencies and Timelines
  • 43 Figure 2.14: Countries that Present the Greatest Regulatory Hurdles
  • 46 Figure 2.15: Perceptions on How Regulatory Times Have Changed in Recent Years
  • 46 Figure 2.16: Perceived Factors Impacting Protraction of Regulatory Timelines
  • 47 Figure 2.17: Duration of Regulatory Submission Timelines: Investigational Stage
  • 47 Figure 2.18: Duration of Regulatory Submission Timelines: Pre-Market Stage
  • 48 Figure 2.19: Duration of Regulatory Submission Timelines: Post-Market Stage
  • 49 Figure 2.20: Frequency of Regulatory Affairs Teams' Contact with FDA
  • 51 Figure 2.21: Perceptions of Specific Regulatory Affairs Challenges
  • 52 Product Case Studies: Meeting with Agencies to Enhance Regulatory Involvement
  • 53 Figure 2.22: Company 19 Case Study 1
  • 54 Figure 2.23: Company 19 Case Study 1, Cont.
  • 55 Figure 2.24: Company 19 Case Study 2
  • 56 Figure 2.25: Company 19 Case Study 2, Cont.
  • 57 Figure 2.26: Company 20 Case Study 1
  • 58 Figure 2.27: Company 20 Case Study 1, Cont.
  • 59 Structuring Compliance Teams to Support Portfolio Demands
  • 60 Matching Compliance Team Structure to Company Needs
  • 62 Figure 3.1: Compliance Group Structure
  • 62 Figure 3.2: Countries/Regions for Which Compliance Is Responsible
  • 63 Figure 3.3: Level of Executive that Heads Compliance Group
  • 64 Figure 3.4: Age of Compliance Groups
  • 65 Figure 3.5: Departments that Fund Compliance
  • 65 Balancing Declining Compliance Resources with Increasing Functional Importance
  • 66 Figure 3.6: Compliance Budgets, by Company
  • 67 Figure 3.7: Percentage of Companies that Outsource a Portion of Compliance Responsibilities
  • 68 Figure 3.8: Percentage of Compliance Budgets Outsourced
  • 68 Figure 3.9: Number of In-House and Outsourced FTEs, by Company
  • 69 Implementing Industry Standards with Compliance Training and SOPs
  • 70 Figure 4.1: Compliance Group Responsibilities
  • 70 Ensuring Industry Standards with Compliance Training
  • 71 Figure 4.2: Intervals at which Companies Train Internal Personnel
  • 72 Figure 4.3: Percentage of Companies that Maintain Quotas for Internal Compliance Training
  • 72 Figure 4.4: How Does the Company Measure Compliance Training?
  • 73 Figure 4.5: Internal Departments that Compliance Trains
  • 74 Figure 4.6: Number of Hours of Training an Internal FTE Receives per Year, by Function
  • 75 Figure 4.7: Number of Hours of Training a Market Access FTE Receives per Year for Company 29
  • 76 Figure 4.8: Number of Hours of Training a Sales FTE Receives per Year
  • 76 Figure 4.9: Number of Hours of Training a Clinical Development FTE Receives per Year
  • 77 Figure 4.10: Percentage of Companies that Train New Hires
  • 78 Figure 4.11: Number of Hours of Compliance Training a New Hire Receives
  • 79 Figure 4.12: Percentage of Companies that Train External Personnel in Compliance
  • 80 Figure 4.13: Number of Compliance Training Hours an External FTE Receives per Year at Company 27
  • 81 Overcoming Challenges in Staffing, Communication and Regulatory Intelligence
  • 82 Figure 4.14: Perceived External Compliance Challenges
  • 82 Figure 4.15: Ratings of Departmental Compliance
  • 83 Figure 4.16: Perception of Internal Compliance Challenges
  • 84 Compliance Team Profiles: Focusing Team Efforts to Develop Effective SOPs
  • 85 Figure 4.17: Company 27 Profile
  • 86 Figure 4.18: Company 27 Profile, Cont.
  • 87 Figure 4.19: Company 29 Profile
  • 88 Figure 4.20: Company 29 Profile, Cont.
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