Good Clinical Practice and Ethics in European Drug Research

Good Clinical Practice and Ethics in European Drug Research

by Peter Bennett
     
 

ISBN-10: 0861971213

ISBN-13: 9780861971213

Pub. Date: 10/28/1994

Publisher: Bath University Press

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…  See more details below

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.

Product Details

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

Table of Contents

Preface
1Implementation of the EC Good Clinical Practice requirements and their ethical dimension1
2Experiences with the ethical review process and the Danish approach17
3Current experience in the Nordic countries27
4GCP: current events in Eastern Europe37
5Good Clinical Practice and ethics in European drug research: a case study from the pharmaceutical industry49
6Sponsors' experience: case studies by a contract research organisation67
7The European Ethical Review Committee: experience with multi-location clinical trials75
8FDA ethical requirements and the responsibilities of an independent IRB81
9Education of ethics committees: scientific information and the review process89
10A few thoughts on informed consent97
11Ethical issues in adverse events107
12Ethical aspects of drug research in psychiatric patients117
13Of mice and men: things are much more difficult in men125
Appendix 1. EEC Note for Guidance: Good Clinical Practice for clinical trials on medicinal products in the European Community135

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