CMR Workshop Series – serie
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3 produkter
2 213 kr
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499 kr
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As 1992 looms on the horizon and preparation is made for the completion of the internal market in Europe, the CMR realised the value of addressing some of the issues involved and defining the objectives and achievements of medicines regulations in a number of EEC countries in comparison with Japan and the USA. The overall aim was to use the lessons of past experience to determine the most appropriate way forward. The final debate focused on two possibilities for assessing and granting marketing authorisations for Europe, namely mutual recognition or a centrally organised European Med icines Office. These two views were discussed in detail at both the workshop at the Ciba Foundation and the international symposium at the Royal College of Physicians. It is hoped that this sharing of ideas and the publication of the proceedings of this fifth CMR Workshop will have encouraged all concerned to continue the debate so that the final outcome will be the establishment of an efficient system in the community for the benefit of patients, the practising physician and the pharmaceutical industry. We would like to take this opportunity of thanking Brenda Mullinger for the considerable amount of scientific and editorial work that she carried out on the manuscripts, Sheila Wright for providing the secretarial support which allowed the proceedings to be submitted to Kluwer Academic Publishers on disk and Sandra Cox who organised the administrative aspects so vital to the successful running of a Workshop and major international symposium. S. R.
559 kr
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The third CMR Workshop prov. ided the opportunity for a group of experts from the Industry, academia and the regulatory authorities to meet and discuss ways and means by which risk benefit decisions are made during the various stages of drug development. It became apparent from the discussions that took place in October 1985, at the CIBA Foundation, that decisions are often made with limited data and inadequate methodology. The conclusions drawn from the day's deliberations were as follows: 1. Current methodology for assessing risk and particularly benefits must be improved; 2. Safety must be assessed in association with benefits as it is ultimately the benefit/ risk ratio which should decide the future of medicines; 3. Risks from medicines must always be viewed in relation to the risks from untreated diseases. It seemed to be the consensus of the group that such a meeting was both useful and informative and, hopefully, the publication of these proceedings will stimulate further discussion in this important area which may improve the decision-making process in drug development. The Editors wish to thank the participants for contributing to the Work shop, together with Dr. Cyndy Lumley for providing the initial transcript of the meeting and Mrs Sheila Wright for producing the final version and for carrying out all the additional work that is entailed in producing such a publication. Professor S. R. Walker A. W.