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

Product Details

Published:

01/01/2006

ISBN(s):

1931879486

Number of Pages:

120

File Size:

1 file , 710 KB