Organisation of Medical Sciences

The CIOMS is based in Geneva and operates under the WHO umbrella. It has served as a fomm for discussions between regulators and industry on a variety of pharmacovigilance topics since the 

CIOMS II International reporting of periodic safety update summaries (1992) 

This report made the original proposals for the format and content of PSURs. Since 1992, requirements for PSURs have been widely implemented as a regulatory requirement (see Chapter 5) and a harmonised guideline has been adopted through the International Conference on Harmonisation (see below). 

CIOMS III Guidelines for preparing core clinical-safety Information on drugs (1995) 

This report addressed the problem of variations in safety labelling around the world by proposing that manufacturers should develop a core data sheet that contains all the relevant safety information which needs to be included in all countries where the drug is marketed. This is effectively a minimum standard - additional information may be included in some countries - and it also serves as the basis for deciding whether or not a specific adverse reaction is listed (i.e. expected) or not. The report made specific recommendations as to what should be included in core safety information, and when and how it should be included. 

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CIOMS. Working Group II Final Report. Geneva Coimdl for International Organisations of Medical Sciences, 1992. 

International standards for ADR reporting have been developed since the late 1980s through the Council for the International Organisation of Medical Sciences (CIOMS) and International Conference on Harmonisation (ICH) - see Chapter 6. 

Source Council for the International Organisations for Medical Science. Safety Requirements for the First Use of New Drugs and Diagnostic Agents in Man. Geneva QOMS (WHO) 1983. 

Acknowledgements. The authors gratefully acknowledge Mrs. S.M. Gersen-van Zadel for expert preparation of the manuscript and Mr. J.RN. Ruiter for artwork. Supported by grants from the Dutch Organisation for Scientific Research (NWO), Medical Sciences and the Princess Beatrix Ponds, Den Haag, The Netherlands. 

Elsevier is the leading publisher in the world for scientific and technical information. The group Reed Elsevier publishes thousands of scientific and technical journals, magazines and trade journals, in materials engineering, chemistry, physics, construction, medical sciences, etc. and also organises a number of very important trade shows such as BATIMAT, the biggest trade show for construction in the world, composite shows and as well as others. 

One does hear about the importance of the creation of Les Houches for the rebirth of French science, after its wartime collapse. My aim here has been to stress the international impact, beyond the specific problems of the France of 1950. The creation of the School of Physics at Les Houches represents an important advance in the organisation of world scientifc research, an innovative new model which has now become an essential element everywhere. I would like to congratulate the Scientific and Medical University of Grenoble and her President who is here with us for its having taken the School under its auspices. 

Line functions and staff functions within the organisation have to be clearly identified. Line is associated with process flow. Line functions have direct responsibility and have the authority and power for realising the mission of the company. Knowledge of reporting lines is useful. Staff supplies information, materials and advices to the line . Staff functions are e.g. counselling on human resources, on procedures, on analytical methods and on systems, on managing a science based service department handling medical information, complaints and recall. A QP or hospital pharmacist may have both line and staffs function(s). 

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