Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF DECEMBER 15,1997 PSA#1992

IFPMA, 30, rue de Saint-Jean, PO Box 9, CH-1211 Geneva 18

L -- MAINTAIN, DISTRIBUTE, IMPLEMENT AND DEVELOPE TERMINOLOGY FOR THE MEDICAL DICTIONARY FOR REGULATORY TERMINOLOGY SOL International Conference on Harmonization DUE 043098 POC Miss Margaret Cone, 41223401200 The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 as a joint regulatory/industry project to develop harmonized requirements for the EC, Japan and the USA. The Food and Drug Administration is the regulatory sponsor of ICH in the United States. The Medical Dictionary for Regulatory Activities Terminology has been developed for regulatory authorities and the industries they regulate for utilization in data entry, retrieval, evaluation, presentation and communication in pre- and post-marketing phases of the regulatory process. The long-term success of the terminology is critically dependent on the establishment of effective maintenance arrangements to ensure that the terminology is updated and continues to evolve in response to user needs. Therefore, the ICH seeks services in connection with the maintenance, distribution, implementation and ongoing development of the terminology, as well as support for its users. Documentation is available to interested parties which includes the specifications for the call for tenders plus details of ICH and the development of the terminology, and electronic copies of version 1.5 -- an interim draft of the terminology. Responses should be submitted in English and Japanese. They may be submitted individually or in association with others. In the event of submission of a joint response, one of them is to be designated as the prime contractor for the purpose of the contract. All responders shall keep their offer open for 1 (one) year from the date of closure of this announcement. All responsible sources may receive a documentation package if request is timely received to: Miss Margaret Cone, IFPMA, 30, rue de Saint-Jean, P.O. Box 9, CH-1211 Geneva 18, Switzerland. (0345)

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