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The ISPE Baseline® Guides were initiatives mobilized after a team of executives from all around the industry came together. We listened to what the regulators wanted and needed. We created a solution without the barriers of politics and lobbying efforts, and we delivered.

Fred Sexton, V.P. Technical Operations
Purdue Pharma LP, USA

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Investigational Products
Investigational Products Publications

ISPE's Clinical Trial Materials and Investigational Medicinal Products resources have been created to familiarize new investigational trial materials professionals with the terms and related information they need to be successful in their field. These are excellent tools to bring employees up to speed quickly and efficiently - saving your company valuable resources. They also serve as useful references for experienced professionals. As many US pharmaceutical and biotechnology companies provide clinical trial materials throughout the world, it is imperative to understand other country regulations.



Comprehensive Guide to Clinical Materials

Published July 2006
Pages: 120 

Comprehensive Guide to Clinical Materials:
A Handbook for Clinical Material (CM) supply chain management; an ever-expanding and complex field. Government agencies require that staff members are fully trained in the appropriate regulations and GMPs, 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.

 Order the bound version from ISPE On-line Store
  Also available as a secure PDF* for immediate download
  from Techstreet/Thompson Scientific

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Introductory US Clinical Materials Training Guide

Published: October 2002
Pages: 42
 
The Introductory US Clinical Trial Materials Training Guide has been created to familiarize new investigational trial materials professionals by pulling together the terms and related information they need to be successful in their field.

 Order from the ISPE On-line Store


Investigational Materials Sample Retention Guide (Slide Rule)

This Guide, a supplement to the Introductory US Clinical Trial Materials Training Guide, assists users in quantity and retention time for sample products.

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Investigational Medicinal Products Training Guide

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