Level: Fundamental/Intermediate - Application
ISPE CEUs: 1.3
Type: Classroom Training Course
This course is also available online. Clinical Trial Materials.
CTM Managers continue to play a critical role in a company’s ability to efficiently bring life-saving products to market. Unfortunately in today’s high-pressure and time sensitive research environment, CTM Managers frequently learn while focusing on the specific requirements of an assigned trial, with less priority being given to the critical need for solid training in all aspects of CTM management.
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot. The course will also cover the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology will be covered to ensure familiarity with all the necessary concepts.
Participants will discuss the different roles of the Clinical Team and how they interact with the CTM group. We will also cover current Good Manufacturing Practices (cGMPs) and how they are implemented in the packaging process. The course will also provide a dictionary of terms used in the CTM industry and how they apply to our daily business. After taking this course, you will be better prepared to manage every aspect of CTM for your clinical trials!
Participants will receive a complimentary copy of the ISPE Good Practice Guide: Booklet Labels electronic download