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10238 WEBINAR: Structured Product Labeling – 2010 Update & Downstream Use of SPL Data
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Title:
WEBINAR: Structured Product Labeling – 2010 Update & Downstream Use of SPL Data

Date(s) And Time(s):
Aug 12 2010 11:00AM - Aug 12 2010 1:00PM

Interest Area(s):
Document Management/ eSubmissions,Regulatory Affairs,Research & Development,Medical Writing

Overview:

This webinar will explore downstream utilization of SPL data.

FEATURED TOPICS
• Downstream Utilization of SPL Data
• Overview of the technical and regulatory information included in electronic content of labeling submissions to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)
• Technical and regulatory information included in electronic drug establishment registration and drug listing submissions to CBER, CDER, & Center for Veterinary Medicine (CVM)
• SPL Release Five



Learning Objectives:
At the conclusion of this webinar, participants should be able to:
• Identify information to be included in electronic content of labeling submissions electronic drug establishment registration and drug product listing submissions and understand technical validation procedures applied by FDA
• Discuss the uses of SPL data in the future
• Describe SPL Release Five from a data standards perspective

Target Audience:
Professionals involved in:
• Regulatory affairs
• Dictionaries/Data standards
• Healthcare Information Providers
• Information management
• Generic manufacturing
• Manufacturing: Drug Substance, Drug Product, Packaging
• Over-the-counter drug development

Event Code:
10238

Contact Information:
Questions about this Webinar? Contact Wendy Moyer at the DIA office in Horsham, PA by telephone +1.215.293.5810, fax +1.215.442.6199, or email Wendy.Moyer@diahome.org.