chapter  11
14 Pages

Overseas Trials

ByDiane Mustafa, Frank Reale, Steven Jacobs

The international arena plays a critical role in any pharmaceutical development program. In an effort to accelerate the development process, American companies have had to expand their patient population pool. This expansion can be rapidly achieved by including patients from around the globe. The practice of conducting clinical trials overseas has mushroomed, with over 100 countries involved. And, this list is constantly growing. More than ever, for those who process drug supplies for clinical trials, there is a need to know the regulatory requirements of each of these countries and tounderstand the global constraints. Regulatory requirements for conducting international clinical trials, and consequently the uses of clinical trial materials (CTMs), are constantly changing.