|
COMMERCE BUSINESS DAILY ISSUE OF DECEMBER 15,1997 PSA#1992IFPMA, 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) Loren Data Corp. http://www.ld.com (SYN# 0062 19971215\L-0001.SOL)
L - Technical Representative Services Index Page
|
|