EUROPEAN COMMISSION AWARDS CONTRACT TO STUDY REQUIREMENTS FOR MEDICINES AGENCY
EUROPEAN COMMISSION AWARDS CONTRACT TO STUDY REQUIREMENTS
FOR MEDICINES AGENCY
PRINCETON, N.J., March 2 /PRNewswire/ -- The European Commission has awarded a contract for a one-year study of requirements for the proposed European Agency for the Evaluation of Medicinal Products (EMA), which would be responsible for coordinating scientific evaluations and supervising marketing of medicines throughout the European Community.
Under terms of the contract won by DRT Europe Services (DRTES), Touche Ross Management Consultants and G.H. Besselaar Associates will lead a study of the managerial structures and financial resources needed to establish the agency.
Primary objectives of the study are to provide estimates of the workload, income and costs of the agency over its first five years of operation, to recommend appropriate management structures for the agency and to consider its personnel requirements, recruitment policies and career structures.
The study also will deal with various aspects of the operation of the centralized and decentralized community drug-registration procedures, pharmacovigilance alerts, the assessment of residue limits for veterinary products and the coordination of inspections.
Principle objectives of the study are to:
-- Estimate the agency's prospective workload for an initial five- year time period for each of its proposed functions;
-- Describe detailed tasks to be undertaken by the agency in fulfilling its functions;
-- Evaluate translation, interpreting and meeting requirements;
-- Recommend an appropriate management structure;
-- Assess agency staff needs and requirement for outside expertise;
-- Consider availability of necessary personnel and recommend suitable recruitment and career structures;
-- Evaluate the agency's material requirement in terms of office space, equipment and information management facilities;
-- Estimate financial costs (both set-up costs and continuing costs) over a five-year period;
-- Estimate potential income and examine the basis on which fees could be set;
-- Estimate cost to the CEC budget and identify the savings to national authorities which would offset this.
An interim report is required after six months; the full report is required within one year.
The study is to be carried out using existing information and by consultation with the national regulatory bodies, European and national industry federations and major pharmaceutical companies. Relevant experience from other countries, e.g. the United States and Switzerland, also will be considered.
It is anticipated the Council of Ministers will make a final decision on the role and structure of the European Medicines Agency during the course of 1992.
/NOTE TO EDITORS: Touche Ross Management Consultants and DRTES are members of DRT International, one of the world's leading accounting and consulting organizations, with 57,000 people in over 100 countries. In Europe, DRT International's 17,000 partners and staff service thousands of clients from over 250 offices in 25 countries.
G.H. Besselaar Associates is an international contract research organization founded in 1976 to provide clinical research, biostatistics, data management and regulatory affairs services to clients in Europe, North America, Australia and Japan. G.H. Besselaar Associates, with worldwide headquarters in Princeton, N.J., U.S., is a unit of Corning Laboratory Sciences Incorporated, a wholly owned subsidiary of Corning Incorporated, Corning; New York, U.S./
/CONTACT: A.C. Miller of G.H. Besselaar Associates, 609-452-8550/ CO: European Commission; G.H. Besselaar Associates ST: New Jersey IN: SU: SH-OS -- NY032 -- 3914 03/02/92 11:27 EST