| Nom | Support | Langue | Disponibilité | Date d'édition | Prix | ||
|---|---|---|---|---|---|---|---|
|
PDF sécurisé |
Anglais |
Active |
01/01/2006 |
482,00 € |
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Détails
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
Informations supplémentaires
| Auteur | International Society for Pharmaceutical Engineering |
|---|---|
| Edité par | ISPE |
| Type de document | Guide |
| EAN ISBN | 1931879486 |
| Nombre de pages | 120 |
| Mot-clé | Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals |
