Pharmaceutical Compliance Best Practices

$1,995.00

An effective, empowered pharmaceutical compliance function ensures that companies avoid the cost and trouble associated with fines, recalls, audits and more. This report’s benchmark data and in-depth team profiles detail compliance structures, staffing, resources and best practices across different company types and industry sectors. Build an organization that features both strong central oversight and specialized on-the-ground expertise. See how other organizations face key challenges, such as keeping pace with the everchanging array of national and international standards — and how they leverage digital training tools to maximize employee understanding, track training, and identify and eliminate trouble areas.

Download a benchmarking report summarySpeak to a pharmaceutical benchmarking expert

Report Details

Publication Date: May 2012
Pages: 119
Chapters: 2
Metrics: 500+
Charts/Graphics: 73

Top Reasons to Buy this Pharmaceutical Compliance Report

Strengthen the Role of Pharmaceutical Compliance within Your Organization: Team structure is critical to success. Use the report’s team profiles to build effective, empowered pharmaceutical compliance groups. Understand internal alignment models, leadership, staffing levels and outsourcing.

Create, Train, and Monitor Pharmaceutical Compliance Effectively: Striking the balance between over- and under- compliance is an art and a science. Leverage digital training to keep employees up-to-date with the latest policies and regulations, enforce employee accountability and escalate problems via proper channels. Explore training metrics to spot recurring trouble spots, improve processes and avoid costly compliance issues.

Manage a Growing List of Global Standards and Regulations: Pharmaceutical compliance teams juggle a staggering number of laws, regulations and guidelines in markets around the globe, which means increased — and increasingly complicated — workloads. Implement best practices and successful processes to meet the internal and external challenges of this reality head on.

This report provides detailed benchmark data and case studies for teams seeking to improve their organizations’ approaches to compliance. With metrics on budgets, staffing and support, as well as specific challenges, the findings provide a guide for compliance teams across all company types and sizes

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource.

Excerpt from Pharmaceutical Compliance Best Practices

The pharmaceutical industry relies heavily on compliance teams to ensure that business operations do not run afoul of regulatory bodies. In addition to several other tasks, these teams have the critical triple mandate of developing standards, training staff on those standards and monitoring employees to gauge adherence to those standards. They operate across a range of functions within companies to ensure compliance is enforced from product development to commercialization.

Nonadherence costs the industry billions of dollars annually in fines, recalls, audits and other punitive noncompliance actions by governmental agencies. Systemic noncompliance can spell the demise of whole companies. Strict adherence to the business rules, on the other hand, is the competitive advantage companies are looking for: the first to stumble on regulations could quickly find itself struggling to catch up with companies that avoided such trouble. To complicate matters, compliance teams juggle an increasingly dizzying array of international standards and regulations.

Table of Contents

9              Executive Summary

11           Study Methodology

12           Study Definitions

13           Profiled Companies and Therapeutic Areas

14           Three Key Recommendations

21           Compliance Team Structure, Challenges, Budgets and Staffing

22           Structure: Align Compliance with Internal Expertise

40           Time and Budgets Spent on Audits, Training and Documentation

50           An Ounce of Prevention: Compliance Training Processes and Metrics

60           Compliance Team Budgets and Staffing

69           Compliance Challenges: Internal Versus External

77           Compliance Team Profiles

78           Company I Compliance Team Profile

84           Company J Compliance Team Profile

89           Company O Compliance Team Profile

94           Company F Compliance Team Profile

99           Company C Compliance Team Profile

105         Company R Compliance Team Profile

110         Company K Compliance Team Profile

115         Company M Compliance Team Profile

Charts and Graphics

Executive Summary

Three Key Recommendations

16           Figure E.1: Internal Compliance Units: All Companies

Compliance Team Structure, Challenges, Budgets and Staffing

Structure: Align Compliance with Internal Expertise

23           Figure 1.1: Structure of Compliance Function: All Companies

24           Figure 1.2: Structure of Compliance Function: Top 20 Companies

25           Figure 1.3: Structure of Compliance Function: Top 50 Companies

26           Figure 1.4: Structure of Compliance Function: Small/Biotech Companies

26           Figure 1.5: Structure of Compliance Function: Device Companies

30           Figure 1.6: Frequency of Contact with Regulatory Agencies

32           Figure 1.7: Functions within Compliance Teams’ Jurisdiction: All Companies

33           Figure 1.8: Functions within Compliance Teams’ Jurisdiction: Top 20 Companies

34           Figure 1.9: Functions within Compliance Teams’ Jurisdiction: Top 50 Companies

35           Figure 1.10: Functions within Compliance Teams’ Jurisdiction: Small/Biotech Companies

36           Figure 1.11: Functions within Compliance Teams’ Jurisdiction: Device Companies

37           Figure 1.12: Level of Executive Leading Compliance Team: All Companies

38           Figure 1.13: Level of Executive Leading Compliance Team, by Structure

39           Figure 1.14: Average Age of Compliance Function, by Company Type

Time and Budgets Spent on Audits, Training and Documentation

44           Figure 1.15: Percentage of Budget and Time Spent, by Compliance Activity: All Companies

46           Figure 1.16: Percentage of Budget and Time Spent, by Compliance Activity: Top 20 Companies

47           Figure 1.17: Percentage of Budget and Time Spent, by Compliance Activity: Top 50 Companies

48           Figure 1.18: Percentage of Budget and Time Spent, by Compliance Activity: Small/Biotech Companies

49           Figure 1.19: Percentage of Budget and Time Spent, by Compliance Activity: Device Companies

An Ounce of Prevention: Compliance Training Processes and Metrics

51           Figure 1.20: Percentage of Compliance Teams that Conduct

51           Internal Training

52           Figure 1.21: Frequency of Internal Compliance Training

53           Figure 1.22: Reasons for Ad Hoc Internal Compliance Training

54           Figure 1.23: Internal Compliance Training Units: All Companies

56           Figure 1.24: Internal Compliance Training Metrics:Top 20 and Top 50 Companies

57           Figure 1.25: Internal Compliance Training Metrics: Small/Biotech and Device Companies

58           Figure 1.26: Percentage of Compliance Teams that Conduct New Hire Training

59           Figure 1.27: Percentage of Compliance Teams that Conduct External Personnel Training

Compliance Team Budgets and Staffing

61           Figure 1.28: Compliance Budgets for 2010–2012, by Company Type

62           Figure 1.29: Source of Compliance Team Funding: All Companies

64           Figure 1.30: Average In-House and Outsourced FTEs per Compliance Team, by Company Type

65           Figure 1.31: In-House and Outsourced Compliance FTEs: Companies that Outsource

66           Figure 1.32: Average Percentage of Outsourced Compliance FTEs: All Companies that Outsource

67           Figure 1.33: Staffing Trends from 2010–2012: All Companies

68           Figure 1.34: Three-Year Predictions of Staffing Trends: All Companies

Compliance Challenges: Internal Versus External

69           Figure 1.35: Ratings of External Compliance Challenges: All Companies

71           Figure 1.36: Ratings of Internal Challenges: All Companies

72           Figure 1.37: Ratings of Internal Challenges: Top 20 Companies

73           Figure 1.38: Ratings of Internal Challenges: Top 50 Companies

73           Figure 1.39: Ratings of Internal Challenges: Small/Biotech Companies

74           Figure 1.40: Ratings of Internal Challenges: Device Companies

75           Figure 1.41: Ratings of Departmental Compliance: All Companies

Compliance Team Profiles

Company I Compliance Team Profile

80           Figure 2.1: Background and Structure: Company I

81           Figure 2.2: Compliance Team Resources: Company I

82           Figure 2.3: Compliance Team Activities: Company I

83           Figure 2.4: Ratings of Challenges: Company I

Company J Compliance Team Profile

85           Figure 2.5: Background and Structure for Company J

86           Figure 2.6: Compliance Team Resources: Company J

87           Figure 2.7: Compliance Team Activities: Company J

88           Figure 2.8: Ratings of Challenges: Company J

Company O Compliance Team Profile

90           Figure 2.9: Background and Structure for Company O

91           Figure 2.10: Compliance Team Resources: Company O

92           Figure 2.11: Compliance Team Activities: Company O

93           Figure 2.12: Ratings of Challenges: Company O

Company F Compliance Team Profile

95           Figure 2.13: Background and Structure: Company F

96           Figure 2.14: Compliance Team Resources: Company F

97           Figure 2.15: Compliance Team Activities: Company F

98           Figure 2.16: Ratings of Challenges: Company F

Company C Compliance Team Profile

101         Figure 2.17: Background and Structure: Company C

102         Figure 2.18: Compliance Team Resources: Company C

103         Figure 2.19: Compliance Team Activities: Company C

104         Figure 2.20: Ratings of Challenges: Company C

Company R Compliance Team Profile

106         Figure 2.21: Background and Structure: Company R

107         Figure 2.22: Compliance Team Resources: Company R

108         Figure 2.23: Compliance Team Activities: Company R

109         Figure 2.24: Ratings of Challenges: Company R

Company K Compliance Team Profile

111         Figure 2.25: Background and Structure: Company K

112         Figure 2.26: Compliance Team Resources: Company K

113         Figure 2.27: Compliance Team Activities: Company K

114         Figure 2.28: Ratings of Challenges: Company K

Company M Compliance Team Profile

116         Figure 2.29: Background and Structure: Company M

117         Figure 2.30: Compliance Team Resources: Company M

118         Figure 2.31: Compliance Team Activities: Company M

119         Figure 2.32: Ratings of Challenges: Company M