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***** ICH GCP E6 (R2) compliant *****
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by Prof David Hutchinson
Pharmacists are often forgotten when it comes to trial briefings.
This quick and easy to read, bullet point, illustrated guide provides vital information that enables trial pharmacists to comply with their important GCP responsibilities relevant to handling study medication in a clinical trial. Following the 10 Golden Rules contained in the book will facilitate compliance with the GCP responsibilities of the investigational site in relation to product handling and accountability. The book contains relevant extracts from ICH GCP guidelines and provides best practice advice based on the latest Royal Pharmaceutical Society guidelines. The book also summarises the requirements of European Directives 2001/20/EC, and takes into account Directive 2005/28/EC, GMP and Annex 13.