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About This Item

 

Full Description

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 cGMPs
  • New EU Regulatory Environment

Other sections of the Guide consider:

  • Project Planning and Management
  • Clinical Trial Design
  • Manufacturing
  • Distribution and Returns