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Question and Answer Document for the Data Quality Webinar held June 4 and 6, 2013 The questions in this document represent all questions that were asked of us during the webinar or submitted to us after the webinar. The
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Company

Animal Drug User Fee Act AE / AEs / Adobe / Computerized Systems / Microsoft / /

Country

United States / /

Event

Product Issues / /

IndustryTerm

magnetic resonance imaging / spreadsheet software / eSubmitter portal / study protocol / study protocols / generation motion picture experts / software formats / investigational pharmaceutical product / food use authorization / manufacturing / manufacturing practice / drug products / effectiveness study protocols / eSubmitter electronic submission tool / control product / /

MedicalCondition

disease / /

Organization

FDA’s Center for Drug Evaluation and Research cGMP / Food and Drug Administration / FDA / Center for Veterinary Medicine DCF / Organisation for Economic Co-operation / OECD / /

Position

investigator / author / veterinarian / director approval / study director / director SEND / clinical investigator / contractor/contributing scientist / General / separate statistician / /

Product

AVC / Submissions Filed / /

ProgrammingLanguage

XML / XML schema / /

Technology

study protocol / XML / study protocols / magnetic resonance imaging / MPEG-4 / extensible markup language / effectiveness study protocols / 11 Study Protocol / digital video / 185 Protocol / uniform resource locator / drug development / MRI / PDF / /

URL

http /

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