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The Institute of Clinical Research (ICR) is continuing its work to promote understanding and raise standards in clinical research with the publication of a new book on the EU Directives.
The Pocket Guide to the EU Directives for Clinical Research provides a summary of the key aspects of the Clinical Trials Directive 2001/20/EC, Good Clinical Practice Directive 2005/28/EC and Good Manufacturing Practice Directive 2003/94/EC. The publication is designed to be read in conjunction with the Directives themselves and provides a useful, easy to read overview.
This compact guide is written by Dr Julie Meeson FICR, a quality assurance consultant who also runs her own company providing quality assurance and training services to pharmaceutical companies and CROs. Julie commented "The EU Directives are critical documents for all clinical research professionals but can be difficult for many to understand.
"The three Directives cover the most extensive changes in European Union clinical trial legislation and our new book will help clinical research professionals better understand and use the Directives in their work."
Another recent addition to the ICR's extensive range of clinical research booklets and monographs is The ICR Guide to Freelancing, which highlights the benefits and pitfalls of freelancing and provides useful tips for starting out on your own.
For corporate and bulk purchases, the ICR can provide ICH GCP and Fundamental Guidelines booklets with customised covers, which can be distributed to staff as part of their continuing professional development or during training courses.
The Pocket Guide to the EU Directives for Clinical Research (ISBN: 9 781905 238675) is priced at £17.00 and is available for purchase via the online shop or from other online booksellers. For further information log on to the ICR website at www.icr-global.org/resources/publications/.