Preparation, Packaging and Labeling of Clinical Trial Materials

Who Should Attend
This survey course will emphasize the procedures and techniques needed to prepare compliant clinical trial supplies. The course is intended for personnel who are new to the clinical supply process, as well as for those who have experience in Clinical Trial Materials (CTM) preparation but want to update or refresh their knowledge. This includes, but is not limited to those involved in:

  • Packaging 
  • Labeling
  • Quality Assurance/Control 
  • Clinical Manufacturing
  • Regulatory Affairs 
  • Research & Development
  • Contract Packaging

Description
The aim of this survey course is to provide an overview and introduction to the many details that must be considered in the design, preparation, packaging, labeling and distribution of clinical trial materials in support of adequate and wellcontrolled clinical studies. Emphasis will be given to practical examples of procedures, components, and regulatory requirements needed to provide acceptable investigational materials. Comparison of the requirements of the United States and Europe and consideration of the harmonization of international clinical studies will be given.

The interrelationships of the industrial pharmacist, clinical research associate, medical monitor, regulatory officer, clinical pharmacist, clinical supplies and quality assurance/control personnel will be discussed. In addition, cGMP will be reviewed to ensure compliance during the preparation, use and return of the trial materials.

The course provides participants the opportunity to share experiences with faculty and colleagues about effective methods to design, produce, package, and label clinical trial materials. The concepts presented during the course are integrated by means of case studies that consider real-world clinical trial supply problems and solutions.