Packaging and Labeling of Clinical Supplies

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?

The webinar will commence with an introduction to the basics concepts of the clinical supply process including packaging and labeling to answer these questions.

Personnel involved in the clinical supply process in any manner need to be well-versed in the A-B-Cs of clinical packaging such as:

• Identifying the type of packaging best suited for the clinical trial
• Process of filling
• GMP documentation required
• Labeling requirements

The webinar instructor will elaborate on all of the above and address several other critical steps in the clinical supply process. An industry expert with over 40 years’ experience in the pharmaceutical industry, he will also discuss best practices for compliance and adhering to a project’s timeline.

Learning Objectives:

• Introduce the basics concepts of clinical packaging and labeling.
• Provide an understanding of the complexities of the work required to prepare investigational materials for clinical trials.

Areas Covered in the Webinar:

• Types and phases of clinical trials
• Types of packaging used in pharmaceuticals
• 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
• Randomization schedules and IVR

Who Will Benefit:

• Entry level clinical supply professionals
• R&D heads of small and start-up companies
• Heads of virtual pharmaceutical companies
• Clinical operations personnel who wish to learn more about the clinical supply process
• Project managers involved in clinical trials

Instructor Profile:

Donald Levine, D.Ph., FAPhA, CQA, has spent 40 years in the pharmaceutical industry with Plough, Inc., Schering-Plough, and Merck. During this period, he has worked in liquid/semi-solid and solid formulations, process development, packaging development, tech transfer, consumer relations, pharmacovigilance, product safety, clinical, clinical operations, and clinical supply. He believes that the wide variety of work experience, in so many areas of R&D, was the key to his leading the global clinical supply group for Merck consumer care from a US domestic operation to a one that supports studies on a global basis. He believes that in addition to getting all the ‘rights’, the one thing a clinical supply professional needs to ensure is to make the supplies as patient friendly as possible in order to increase patient compliance.

Mr. Levine is now president of DJL Pharma Consultants, LLC, and provides consultation and contractors to universities, established pharmaceutical companies and start-up research companies.

Topic Background:

The clinical supply process is one of the more critical functions leading to the success of a clinical trial. It is the responsibility of the clinical supply professional to assure that the right drug, at the right dosage, gets to the right patient in the right package with the right label, right on time. Choosing the proper package can save time, money, and can increase patient compliance. Proper labeling, regardless of the type of study, should be clear, concise and easily understood by the patient. Both these activities should be developed to be as user (patient) friendly as possible.

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.

Large pharmaceutical companies typically have multiple groups dedicated to specific functions such as manufacturing, packaging, labeling and distribution. Smaller companies may have fewer groups or only one that is responsible for the entire process. Start up and virtual companies may not have anyone with clinical supply experience and might try to perform these activities on their own. 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.

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