Association of the British

Trevor M. Jones The Association of the British Pharmaceutical Industry London, United Kingdom Jerome P. Skelly Alexandria, Virginia... 

Anon. Facts and Statistics for the Pharmaceutical Industry. London The Association of the British Pharmaceutical Industry, 2001. http // www.abpi.org.uk/statistics. 

In the United Kingdom, the information sheet provided to the consenting study subject in a clinical trial sponsored by a pharmaceutical company will usually contain a reference to the clinical trial compensation guidelines of the Association of the British Pharmaceutical Industry (ABPI). It is not included in the information sheet of noncommercial studies. Study subjects taking part in clinical trials are not usually paid, unless it is... 

There should be consistency between the possible adverse events described for the study drug in the protocol, investigator s brochure and ICF. Most coimtries have specific requirements for their ICF. It is essential that the requirements are known when the country-specific ICF is prepared. These examples could easily have changed by the time the reader is checking an ICF. In the United Kingdom, reference should be made to the ABPI (Association of the British Pharmaceutical Industry) Clinical Trial Compensation Guidelines. In other countries, for example, Ireland, the study subject is allowed a specific length of time to decide whether to enter the study. 

Association of the British Pharmaceutical Industry/ British Pharmaceutical Market Research Group. Guidelines on Pharmaceutical Market Research Practice. London ABPI, 1992. 

In the period intervening between its interim advice and its final report, the Joint Subcommittee received memoranda from, and met representatives of, the Association of the British Pharmaceutical Industry (ABPl), the BMA, the Pharmaceutical Society of Great Britain and the College of General Practitioners. 

In order to promote a uniform approach to offering compensation to subjects and indemnity to investigators and institutions conducting clinical trials, Medicines Australia has published a Form of Indemnity for Clinical Trials and Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Chnical Trial. These documents are based on those published by the Association of the British Pharmaceutical Industry and are available from www.medicinesaustralia.com.au (the Medicines Australia website). 

The prices of medicines sold to the NHS are controlled in the United Kingdom by the PPRS, negotiated periodically every 5 to 6 years by the DoH with the Association of the British Pharmaceutical Industry (ABPI), for example in 1979, 1986, 1993 and 1999. The PPRS controls the maximum - but not guaranteed - profits that pharmaceutical companies make on the capital they have invested in plant for research, development and manufacturing for sales made to the NHS. (Capital employed by the individual companies... 

ABPI. A Guide to the Pharmaceutical Price Regulation Scheme (PPRS). London Association of the British Pharmaceutical Industry, 1993. 

The Association of the British Pharmaceutical Industry (ABPI) is the trade association representing manufacturers of prescription medicines. It was formed in 1930 and now represents about eighty companies which supply nearly 80 per cent of the medicines used by the National Health Service. 

Paragraphs 10.4 and 12.2 of the Constitution and Procedure for the Prescription Medicines Code of Practice Authority authorize respectively the Code of Practice Appeal Board and the Board of Management of The Association of the British Pharmaceutical Industry to require an audit of a company s procedures in relation to the Code of Practice for the Pharmaceutical Industry to be carried out by the Prescription Medicines Code of Practice Authority. 

The Sponsor shall comply with all guidelines from time to time in force and published by the Association of the British Pharmaceutical Industry in relation to clinical trials and in particular those entitled Clinical Trial Compensation Guidelines (1991) a copy of which is set out in Appendix 3. 

As a result of a number of enquiries to the Medical Affairs Department of the Association of the British Pharmaceutical Industry (ABPI) and the recognition that the media was being increasingly used to advertise for subjects for clinical trials, the ABPI Medical Committee set up a Task Group to develop these guidelines. 

Visiting Professor, University of Surrey Postgraduate Medical School Former Director, Association of the British Pharmaceutical Industry, London Formerly Professional Head of the Medicines Division, DHSS, London... 

Finally, we would like to thank the World Medical Association, The European Medicines Evaluation Agency and the Association of the British Pharmaceutical Industry for permission to reproduce their various documents as appendices to this book. All others who allowed us to quote or use their material are acknowledged in the text, however, a general thanks is appropriate at this point. 

John Griffin was the director of the Association of the British Pharmaceutical Industry from 1984 to 1994. During this time he was a member of the Executive Board of the European Federation of the Pharmaceutical Industries Associations and IFPMA. He chaired the ICH Safety Working Group from 1988 to 1994 and presented papers at ICHl and ICH2 in the plenary sessions. 

Industry View of U.S. CFR Part 11 Association of the British Pharmaceutical Industry Association of Clinical Data Management British Association of Research Quality Assurance The British Institute of Regulatory Affairs British Standard Institute Independent Site... 

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