Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials ProfessionalsInternational Society for Pharmaceutical Engineering / 2006 / 120 pages ISBN: 1931879486

Clinical Material (CM) supply chain management is an ever-expanding and complex field. Government agencies require that staff members are fully trained in the appropriate regulations and cGMPs, and keeping current with the rapidly changing global landscape may present a considerable challenge. The ISPE Comprehensive Guide to Clinical Materials offers guidance in this demanding area.The Guide is designed to provide a valuable tool for the development of in-house training sessions for advanced training, building on the topics covered in the earlier Introductory US Clinical Trial Materials Training Guide' (ISPE 2002).The Guide may be used in a classroom setting and then by attendees to gain a more in-depth knowledge and as reference source for future use. The Guide is divided into sections focusing on: Critical learning points summarized for trainer led sessions, written concisely in bullet format. Detailed information addressing each of the critical learning points and reasons for their importance - for background and more in depth knowledge. Reference sources to provide a comprehensive knowledge base. The Guide has been developed by the ISPE Clinical Materials Community of Practice, including members of the European Investigational Medicinal Products Group (IMPG). This is reflected in a more global approach to regulatory aspects, which include:The Common Technical Document (CTD)Relevant cGMPsNew EU Regulatory Environment Other sections of the Guide consider: Project Planning and ManagementClinical Trial DesignManufacturingDistribution and Returns

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