Publisher's Synopsis
Sets 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 phamaceutical 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.
