Packaging and Labeling of Clinical Supplies

Duration: 60 Minutes
This course will provide the attendee a complete overview of the steps required to properly package and label the supplies for use in a clinical trial.
Clinical Supply
Instructor: Donald J. Levine
Product ID: 500980

Running a clinical supply operation is akin to operating a full-scale pharmaceutical manufacturing facility. The two main differences are clinical supplies are on a smaller scale and typically the steps are conducted only once. Correct labeling of clinical supplies is more complex than one would expect. The type of study, study site locations, GMP/ICH regulations, internal approvals, type and size of the primary package, secondary packaging availability, and local regulations can adversely affect one’s ability to complete the labeling process in a timely manner. Auxiliary labeling, such as patient inserts or investigator instruction sheets are also included in the clinical supply labeling process.

A well-run Clinical Supply operation will make the entire process look easy and flawless. The coordination of the packaging and labeling of supplies can aid in the smooth initiation of the clinical trials.

Areas Covered
  • Types and Phases of Clinical Trials and types of packaging used
  • Basic requirements of a good package
  • Basic documentation for a filling operation
  • Packaging of comparators
  • Secondary packaging – kits
  • Types of labeling used in Clinical supply
  • Labeling requirements
  • Primary and secondary labeling operations
  • Auxiliary labeling issues
  • Booklet labeling Vs labeling for individual countries
Why Should you Attend
The entire gamut of the clinical supply process can be daunting to a novice, and at times, even to the seasoned professional, faced with the need to get investigational drugs to an investigator and ultimately to the patients who will be involved in the clinical trial. Faced with the task, one would begin to ask, "How do I go about getting the job done?" "Where do I start?" "What are the regulations involved?" "What are my options?"

Regardless of the size of the company you represent, if you are involved in the clinical supply process in any manner, you need to be versed in the A-B-Cs of clinical packaging, both the types of packaging best suited for the clinical trial as well as the process of filling and GMP documentation required. This is a basic step in the clinical supply process and its completion can affect the project timeline.

Objectives of the Presentation
Introduction to the basic concepts of clinical packaging and labeling and to provide an understanding of the complexities of the work required to prepare investigational materials for clinical trials.

Who can Benefit
  • R&D Personnel
  • Clinical Supply Scientist
  • Project Managers
  • Clinical Operations
  • CRA
Recorded Session for one participant
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Instructor Profile:
Dr. Donald Levine, D.Ph. is the Founder and President of DJL Pharma Consultants. Prior to this role, Dr. Levine was employed at Plough, Inc., Schering-Plough, Merck Consumer Care for 40 years and retired as Lead, Global Clinical Supply. Approximately 2/3 of his career was spent in Clinical Research and Operations, Product Safety, and Clinical Supply supporting three diverse business groups: skincare, foot care and oral dosage forms. As a result, he has first hand knowledge and experience in clinical development and clinical supplies as it pertains to the IND/NDA studies, Rx-to-OTC switch programs, claim support studies, and project management.

During his last 8 years with Schering-Plough and Merck, business scope changed from primarily domestic (U.S.) study support to global support for the division's clinical and product safety studies. In this role, Dr. Levine had much experience outsourcing projects and gained contacts with many of the major clinical supply vendors in the US, Europe, and Asia. The remainder of his experience was in formulations (liquid, solid and topical dosage forms), process development and technology transfer, packaging development, and Consumer Relations and Pharmacovigilance.

He is a fellow of the American Pharmacists Association. As head of his consulting firm, Dr. Levine currently consults for large and small pharmaceutical companies as well as a state university. In addition, he has also been the presenter for several web cast seminars on topics related to clinical supplies.
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