000			02380cam a2200289 4500
001			9290360429
020			_a9290360429
035			_a(Sirsi) 9290360429
060			_aQZ 42
110	2		_aCIOMS Working Group on International Reporting of Adverse Drug Reactions.
245	0	0	_aInternational reporting of adverse drug reactions : _bfinal report of CIOMS working group.
260			_aGeneva : _bCIOMS, _c1990.
300			_a66 p.
520	3		_aSets out a carefully developed and tested procedure for the standardized reporting, by manufacturers to regulators, of postmarketing adverse drug reactions occurring in foreign markets. The procedure, which is now published in its final form, is the culmination of a three-year project initiated by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO. The main part of the book presents and explains the CIOMS procedure for the international reporting of adverse drug reactions. The procedure, which was worked out and agreed upon by representatives of six regulatory agencies and seven multinational pharmaceutical companies, employs a uniform set of definitions and procedures, a fixed time-frame for submission of the report, and a reporting form with standardized elements and format. Prior to finalization, the scheme was pretested in a two-year pilot project involving seven manufacturers and some 40 affiliates. The second half of the book presents evaluations of the scheme prepared by each of the participating regulatory agencies and manufacturers. While pointing out some problems in the implementation of the scheme and use of the reporting form, these first-hand experiences overwhelmingly underscore the feasibility and utility of the scheme, which has already been adopted for use in the United Kingdom, the United States of America, the Federal Republic of Germany, and Italy.
535			_aDC.CIOMS
550			_aWHODOC
561			_aWHO monograph
596			_a4
650	0	2	_aPharmaceutical preparations _xadverse effects.
650	0	2	_aDrug therapy _xadverse effects.
650	0	2	_aAdverse drug reaction reporting systems.
650	0	2	_aDrug industry.
690			_aPharmaceuticals and Biologicals.
710	2		_aCouncil for International Organizations of Medical Sciences.
008			900626s1990 1 0 eng
942			_2NLM _cMONOGRAPH
999			_c11846 _d11846