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Negotiating the Regulatory Minefield of Process Change

Presented at: The Immunotherapeutics and Vaccine Summit Providence, RI, August 16, 2009

This paper aims to provide the key to successful change control. It covers the design of comparability studies and their application to change control, in the context of the national and international regulations. It also examines how to determine the relationship between the magnitude of the change and the required scope of the comparability studies and the way in which the change is to be reported and approved by the regulatory agencies. Actual case histories illustrate these topics.