Outsourcing Regulatory Activities: How a Policy Can Drive Good Decisions
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0092-8615/2000 Copyright 0 2000 Drug Information Association Inc.
OUTSOURCING REGULATORY ACTIVITIES: HOW A POLICY CAN DRIVE GOOD DECISIONS SUZANNE BATES,PHD, MBA Manager, Worldwide Pharmacovigilance and Epidemiology
ELIZABETH SLOAN,PHARMD Manager, US Regulatory Liaison Eli Lilly & Company, Indianapolis, Indiana
In order to utilize resources more eficiently in an increasingly competitive environment, the pharmaceutical industry is outsourcing a large volume of drug development activities to contract research organizations (CROs). These organizations allow companies to access expertise andor augment internal resources during times of peak demand. Until recently, a majority of this outsourcing activity was focused on clinical development rather than regulatory activities. As companies strive to “do more with less” and “do it fastel; ” howevel; regulatory activities are increasingly being considered f o r outsourcing to enable the eficient use of resources. In order for a company to be successful in the management of the outsourcing process an internal policy should be developed. A policy will communicate the regulatory outsourcing strategy to internal departments and the CRO and provide consistency in outsourcing decisions. The objective of this article is to provide information. which can be used to develop a company specific policy on outsourcing regulatory activities to a CRO. The goals of outsourcing, aspects of policy development, and a framework for decision making, including examples, are discussed. Key Words: Key Words: Contract research organization; Policy; Regulatory affairs; Outsourcing
INTRODUCTION AS THE COMPETITIVE environment within the pharmaceutical industry places increased pressure on companies to get drugs to the market faster, the efficient utilization of resources can provide a company with a competitive advantage. Therefore, contract
Presented at the 35* DIA Annual Meeting June 27-July 1, 1999. Baltimore. Maryland. Reprint address: Suzanne Bates, PhD, MBA, Manager, Worldwide Pharmacovigilanceand Epidemiology, Eli Lilly & Company, Indianapolis, IN 46285.
research organizations are increasingly being relied upon to augment internal resources during peak demands in activity. Additionally, the use of these organizations allows a company to access expertise that may not exist internally, assign appropriate resources to project tasks, and obtain quality strategic input into the drug development plan. In large, multinational pharmaceutical companies, there are often more projects to pursue than internal resources available. These companies must make difficult decisions about how to efficiently allocate internal resources among all of the potential proj-
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ects. CROs provide an option to resource more projects than would otherwise be possible. In small pharmaceutical companies (eg, biotechnology), CROs offer a resource option to partnering or outlicensing the product to a larg
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