This comprehensive study of the clinical supply process will address increasing efficiency in packaging and labeling. It will also detail compliance requirements that have to be met in the process. Participants will enjoy the opportunity to train under an industry expert and understand solutions for some of the most common challenges in the process.
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:
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
Course Provider
Donald Levine,
