Good Clinical Practice and Ethics in European Drug Research

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Overview

On the 18-19th of March 1993 a Symposium entitled 'Good clinical practice and ethics in European drug research' was held in the Eastman Building of the European Parliament in Brussels. It was the third Symposium organised by the European Ethical Review Committee, on this occasion in association with the European Forum for Good Clinical Practice. The Symposium was opened by Prof J L Valverde-Lopez MEP and addressed by Dr F Sauer, Mrs M Donnelly and Dr G-N Fracchia of the European Commission, and by a wide range of other experts selected for their knowledge of the ethics of the clinical evaluation of drugs.
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Product Details

  • ISBN-13: 9780861971213
  • Publisher: Bath University Press
  • Publication date: 10/28/1994

Table of Contents

Preface
1 Implementation of the EC Good Clinical Practice requirements and their ethical dimension 1
2 Experiences with the ethical review process and the Danish approach 17
3 Current experience in the Nordic countries 27
4 GCP: current events in Eastern Europe 37
5 Good Clinical Practice and ethics in European drug research: a case study from the pharmaceutical industry 49
6 Sponsors' experience: case studies by a contract research organisation 67
7 The European Ethical Review Committee: experience with multi-location clinical trials 75
8 FDA ethical requirements and the responsibilities of an independent IRB 81
9 Education of ethics committees: scientific information and the review process 89
10 A few thoughts on informed consent 97
11 Ethical issues in adverse events 107
12 Ethical aspects of drug research in psychiatric patients 117
13 Of mice and men: things are much more difficult in men 125
Appendix 1. EEC Note for Guidance: Good Clinical Practice for clinical trials on medicinal products in the European Community 135
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