In this online 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 Clinical Trial Material (CTM) and how to implement the plan and troubleshoot. The course also covers 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 along with Randomizations will be covered to ensure familiarity with all the necessary concepts. Additional content will focus on the roles of the Clinical Project Team and how they interact with the CTM group and the regulatory framework needed to stay abreast of regulatory changes.
Pharmaceutical professionals that are new to the Clinical Supply area who are involved in the manufacture, review, labeling of clinical trial materials. Pharmaceutical professionals who need to know how to use Interactive Voice Response. Pharmaceutical professionals who want to understand Community of Practice (COP).