ISPE CMHB2006

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

People Who Bought This Also Bought:
ISPE 4IT- ISPE GAMP Good Practice Guide: IT Infrastructure Control and ComplianceISPE 4VLCS- GAMP Good Practice Guide: Validation of Laboratory Computerized SystemsISPE CQ0101- ISPE Baseline Guide: Volume 5 - Commissioning and QualificationISPE STER0199- ISPE Baseline Guide: Volume 3 - Sterile Manufacturing FacilitiesISPE 4GIS- ISPE GAMP Good Practice Guide: Global Information Systems Control and ComplianceISPE 4EDA- GAMP Good Practice Guide: Electronic Data ArchivingISPE 4CALMGMT- GAMP Good Practice Guide: Calibration ManagementISPE BIO0604- ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing FacilitiesISPE 4ERS- GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and SignaturesISPE 5BOUNDUS- GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems