CDISC Mapping and Strategies Implemented
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Category FDA GXP Compliance - Pharmaceuticals;
Deadline: May 16, 2016 | Date: May 16, 2016-May 17, 2016
Venue/Country: Philadelphia, U.S.A
Updated: 2016-04-13 21:36:35 (GMT+9)
Call For Papers - CFP
CDISC requirements to create SDTMs and ADaMs are not easy to understand or apply. There are many rules and standards that must be mastered and maintained across global studies. Pharmaceutical companies and CROs supporting global studies have a need to apply proven methods that reduce confusion and improve documentation. With new members joining the study team, there should be a system to help standardize and automate the FDA submission process.Learning Objective:Upon completing this course participants should:Better understand ODM and SDM modelsBetter understand how SDTM and ADaM metadata play an important role to automate the processKnow how to maintain control terminology and value level metadataBetter understand differences and purpose of DEFINE.XML and DEFINE.PDFUnderstand key differences between SDTM and ADaM Models and Process FlowsUnderstand key differences between the Seven CDISC ClassesHow to create Dataset.XML from SASBetter understand structure and syntax of ODM-XML files using examplesWho Will Benefit:This course is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this unique course. Effective and practical solutions to address real-world issues will be provided.This course is recommended for:SAS Statistical ProgrammersQuality Assurance SpecialistsSAS Statistical ManagersMedical WritersStatisticiansRegulatory Affairs AssociatesClinical Data ManagersNote:Use coupon code NB5SQH8N and get 10% off on registration.For Registration:http://www.complianceonline.com/cdisc-mapping-sdtm-adam-models-sas-odm-xml-seminar-training-80337SEM-prdsm?channel=ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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