Preparation, Packaging and Labeling of Clinical Trial Materials
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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.