1. ¹is a manager in the Mountain View office of PRTM. He has over eight years of experience consulting in life sciences companies in the areas of product development and supply-chain management. Most recently, Greg developed and implemented comprehensive improvements to pre-and post-marketing drug safety policies and procedures at a top-three global pharmaceutical company to align with industry best practices and Japan's new regulatory requirements. Greg earned his MBA from the International University of Japan.
2. ²is a director in PRTM's Japan office. Chris is currently the lead director for PRTM's Life Sciences practice in Asia, with extensive experience in various life sciences functions. Chris's experiences span the globe, with significant work in the USA, Japan and Germany. After moving to Japan in early 2000, Chris led several breakthrough industry studies in various specialty areas of the pharmaceutical industry. Chris earned his MBA from Carnegie Mellon University.

Correspondence: Chris Albani, Life Sciences, PRTM Shinjuku Mitsui Building 30th floor, 2-1-1 Nishi-Shinjuku, Shinjuku-ku Tokyo, 163-0430, Japan, Tel: +81 3 5326 9090, Fax: +81 3 5326 9070, E-mail: calbani@prtm.com

Revised 14 June 2006.

Abstract

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) – starting early on in clinical development – is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area – from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing – pharmacovigilance.