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Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 19, 10:45AM - 12:15PM (Pacific Standard Time)

Session Number:
423

Room Number:
5A

Level:
Intermediate

Type:
Symposium

Title:
Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach

Chair(s):
Maria C. Koster, PharmD
Senior Director International Relations
Vigilex, part of the Xendo Group, Netherlands

Description:
Companies' responsibilities to oversee their adherence to regulations, the quality of case reports across the globe and the benefit-risk profile of their products took on a new meaning in recent years. Now, in the wake of an increasing number of regulatory inspections, warning letters, and transparency, including sharing the results with the general public, many companies are refining the role of their corporate and regional audit functions and auditors will shoulder greater responsibility. This session will discuss the role of the auditing groups and how it is evolving in unprecedented ways.

Learning Objective(s):
Discuss different approaches taken by various companies and their audit functions in different geographic areas.

Presentation(s) & Speaker(s):
Ensuring Standardized Case Quality in Safety and Pharmacovigilance Services through Web-Based Systems
Drew Kilpatrick, PhD
Vice President, Safety and Pharmacovigilance
INC Research, United Kingdom

Alternatives to Traditional Audit Methodologies: Effective Auditing While Risk-Based
Maria C. Koster, PharmD
Senior Director International Relations
Vigilex, part of the Xendo Group, Netherlands

Struggling with Three Inspectors From Different Worlds: Reality and Idealism
Teiki Iwaoka, PhD, MS
Executive Consultant, Director of Drug Safety Outsourcing Planning
CAC EXICARE Corporation, Japan