Packaging and Labeling of Clinical Supplies
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Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500980?expDate=Sep3_2015_Clinical |
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Category Clinical Supply, Clinical Packaging, Clinical label, Investigational Materials, Clinical Trials, Rules and Regulations, Clinical Regulations
Deadline: September 02, 2015 | Date: September 03, 2015
Venue/Country: online Webinar, U.S.A
Updated: 2015-08-25 18:14:33 (GMT+9)
Call For Papers - CFP
Packaging and Labeling of Clinical SuppliesInstructor: Donald J. LevineProduct ID: 500980DescriptionThis 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.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 CoveredTypes and Phases of Clinical Trials and types of packaging usedBasic requirements of a good packageBasic documentation for a filling operationPackaging of comparatorsSecondary packaging ? kitsTypes of labeling used in Clinical supplyLabeling requirementsPrimary and secondary labeling operationsAuxiliary labeling issuesBooklet labeling Vs labeling for individual countriesWhy Should you AttendThe 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 PresentationIntroduction 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 BenefitR&D PersonnelClinical Supply ScientistProject ManagersClinical OperationsCRAFor Registration-http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500980?expDate=Sep3_2015_ClinicalCompliance=Channel=ourglocaldsNOte : Use coupon code 1371 and get 10% off on Registration
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