Name | Support | Language | Availability | Edition date | Price | ||
---|---|---|---|---|---|---|---|
PDF sécurisé |
English |
Active |
1/1/2006 |
€482.00 |
|
Details
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
Additional Info
Author | International Society for Pharmaceutical Engineering |
---|---|
Published by | ISPE |
Document type | Guide |
EAN ISBN | 1931879486 |
Number of pages | 120 |
Keyword | Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals |