Packaging and Labeling of Clinical Supplies

Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500980?expDate=Sep3_2015_Clinical | Edit Freely

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

Instructor: Donald J. Levine

Product ID: 500980

Description

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.

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

For Registration-

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500980?expDate=Sep3_2015_ClinicalCompliance=Channel=ourglocalds

NOte : Use coupon code 1371 and get 10% off on Registration