Pharma and Medical Device Regulatory Affairs

Pharma and Medical Device Regulatory Affairs published by Cutting Edge Information in February, 2010. This report consists of 124 Pages and the price starts from US $ 7695.

Introduction

Abstract

Regulatory teams save time and money as they drive commercial and development goals forward. Build healthy relationships with - and receive clear direction from - regulatory agencies through early, consistent communication.

Immediately draw upon the expertise of more than 50 leading companies across the life sciences spectrum. Whether you' re part of a large pharma or a medical device firm, you' ll find pioneering methods for adapting to the current regulatory climate. Empower regulatory affairs in these main areas:

Structure

Gain greater influence in the design, planning and direction of product development. Organize your team to solve problems more quickly - choose from innovative regulatory affairs structure models.

Communication

Consult timeline and frequency metrics to adjust your communication tactics with regulators. Along the way, explore novel strategies for engaging regulatory agencies - and absorb tailored recommendations specific to pharma and medical device firms.

Budgets and Staffing

Equip your team with the resources to generate the best possible product support. Spending and staffing benchmarks will guide you through resource allocation. Also, track outsourced activities and funding to understand why teams use vendors - and how much they spend on them.

Report Statistics

• Published: 2010
• 124 Pages
• 50+ Companies
• 300+ Metrics

Table of Contents

Executive Summary

• Study Definitions
• Profiled Companies and Therapeutic Areas
• Five Key Findings and Recommendations

Integrating Regulatory Affairs with Product Development

• Internal Process and interaction with Product Teams
• Regulatory Affairs Structure
• Regulatory lntelligence

Communicating with Regulatory Agencies

• Regulatory Affairs and the Current Environment
• Effective Communication with Regulatory Agencies (Pharmaceutical Companies)
• Effective Communication with Regulatory Agencies (Medical Device Companies)

Regulatory Affairs Staffing and Budgets

• Regulatory Affairs Staffing
• Regulatory Affairs Budgets
• Regulatory Affairs Outsourcing

CHARTS AND GRAPHICS

Executive Summary

• Figure E.1 : Average lncrease in Regulatory Affairs Budgets by Company Type: 2007 to 2010

Integrating Regulatory Affairs with Product Development

• Figure 1.1 : Level of Regulatory Affairs Integration with Other Functions

Internal Process and Interaction with Product Teams

• Figure 1.2 : Average Number of Years Regulatory Affairs Function Has Existed

Regulatory Affairs Structure

• 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

Related Reports