Assembling International Regulatory Submissions: A Simplified Approach
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Drug Informarion Journal, Vol. 32. pp. 1169-1171. 1998 Printed in the USA. All rights reserved.
Copyright 0 1998 Drug Infomalion Association Inc.
ASSEMBLING INTERNATIONAL REGULATORY SUBMISSIONS: A SIMPLIFIED APPROACH ROBERTG. RHORER Senior Research Information Scientist, Pfizer Central Research, Groton, Connecticut
SUSANLANDIS Manager, Document 8c Information Management Systems, Pfizer Animal Health Group, New York, New York
JESPER P. LORENZEN Research Information Scientist, Pfizer Central Research, Sandwich, United Kingdom
This paper provides a process for developing and assembling worldwide regulatory dossiers. It is based on having a regulatory filing strategy and an infrastructure in place in advance to create, review, file. and find documents. The benefits of keeping it simple will be explained. Key Wonk Worldwide regulatory dossiers; Manageable components; Organization
THE DEVELOPMENT AND assembly of worldwide regulatory dossiers, a common practice in most global pharmaceutical companies today, can seem overwhelming, especially when viewed as a single event. Approached as a process, however, the entire worldwide regulatory strategy can be broken down to its more manageable components. Each component of that process may be simplified and accomplished in such a manner so as to allow an efficient, timely assembly of a well-organized submission, with the least disruption to the business, and with optimal utilization of existing manpower. It is nor technology that makes the system “simple” or even that makes it work. The technology does not dictate how people
Presented at the DIA Workshop “Document Preparation for the Global Pharmaceutical Industry.” September 1997. Bruges, Belgium. Reprint address: Roben G. Rhorer. Senior Research Information Scientist, Ptizer Central Research, Eastern Point Rd., Groton. CT 06340.
work. Basic document management principles which have been available since before computers are the underpinnings of the entire system. These basic principles structure the system. The basic document management principles, such as each document has one “owner,” consistent document naming conventions, hierarchical structure within which to file documents, written procedures, and training of all staff involved in the process have been in use in the library world for centuries. Classification systems such as those in use in the United States Library of Congress and The British Library have served to organize information for the purpose of later finding and using it for quite some time. In systems such as these, once the user has been trained, he can usually locate the information he needs without the assistance of an information professional. Likewise, in the internstional regulatory submission process, based on a regulatory filing strategy planned in advance and an infrastructure and procedures
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Robert G. Rhorer, Susan Landis, and Jesper P. LorenZen
already in place, the documentdcomponents needed are easily locate
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