Quality Risk Management

Quality Risk Management

Transforming Quality into a Fundamentally New Approach

These slides and the content of this presentation represent the work and opinions of the author and do not constitute official positions of Quality Risk Management Associates, LLC or any other organization. Graphics, figures and data contained herein are for illustrative purposes and are not representative of actual data.

Objectives of this Presentation

Transforming our approach to quality How QRM will help us QRM Concepts QA/QC Governance Model Benefits of QRM

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Quality is managed between three constituencies ? Management, QC and QA

The Quality Management Triangle

Mgmt Oversight

Quality governance as part of management oversight

"Independent" quality assurance through audits

Quality Assurance

(QA)

Quality Control

(QC)

Quality control built into business processes

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What is a risk and what is Quality Risk Management?

Key Definitions

Risk

Quality Risk Management

(QRM)

Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm

Quality Risk Management (QRM) is a systematic process consisting of ? Risk identification ? Risk assessment ? Risk mitigation ? Risk avoidance/reduction ? Communication

QRM supports better decision making by providing greater insight into risks and their impacts and helps to make proactive decisions

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The objective of quality risk management is to ensure safety of patients and integrity of data

Objectives of Quality Risk Management in GCP & Pharmacovigilance

Core Objectives

Safety Processes

in all clinical trials and post-marketing surveillance activities

Data Integrity

of data created in these trials and activities

Derived Objectives

SOP and Regulatory Compliance

Robust processes

Consistency across all entities

Transparency

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Clear need to change our approach to Quality

Higher expectations of Quality across industry

Internal ? Need for early detection of critical quality issues ? Need for transparency and prioritization of quality risks ? Limitations of current auditing approach, calling for range of new

"instruments" ? Need to optimize resources in teams and functions

External ? Increasing regulatory pressure ? More inspections ? Inspections in new territories ? New approach to inspections: From trial/clinic-centered to systems review ? Growing media scrutiny of compliance, or lack thereof: Compliance is sustainability factor

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Major challenge #1: The numbers are against us Audits cover only about 2% of clinical related activities

Focus of Risk Mgmt

Inaccurate incomplete

Safety Processes

data

Patient Safety

Data Integrity

GCP & Pharmacovigilance Entities

PPhhaarrmmaacoco

101 HQ functions

102 Affiliates

CROs Labs Manuf . Others

103 Partners

104 Trial Centers

Audit Coverage

250-300 Audits ~20,000 Entities

= < 2% Audit Coverage

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Major challenge #2: Rising rate of regulatory inspections

Early detection of risk is essential

Num ber of Inspections

35 30 25 20 15 10

5 0

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Local Authority Inspection - USA (FDA) Local Authority Inspection - Japan Local Authority Inspection - France Other Inspections

Source: Health Authority Analyses (Last update December 21st, 2007)

FDA Foreign Inspection Local Authority Inspection - UK Local Authority Inspection - Germany

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