Data Quality & Record Integrity in Regulatory Submissions – NDA, ANDA, BLA, 510(k)

$349.00

Summary

FDA submission reviewers are trained to be skeptical of your data in your submission; they’ll spend months examining the proof behind your claims of safety and efficacy.  This recorded seminar shows you exactly what FDA reviewers are looking for, and then lays out a practical action plan to get your nonclinical and clinical data ready for FDA scrutiny.

Learning points

  • See the 73 specific questions FDA reviewers ask of a submission’s data integrity
  • Learn how answers to these questions determines a submission’s chance of success
  • Nine critical challenges to ensuring clinical data integrity
  • When and why to conduct independent self-analyses of submissions data
  • Steps to head-off many data quality questions during a submission review
  • Understand why data monitoring committees are only a fraction of the solution
  • Learn what to expect from the endpoint adjudication process
  • Ten steps involved to prove data quality in submission
  • What a cost-effective, practical strategy looks like … how to get there

And much more

Get 12+ documents for easy & quick implementation

  • Checklist:  Regulatory submission data integrity-controls matrix
  • Checklist:  Pre-study data management & controls
  • Checklist:  Post-study data management & controls
  • Checklist:  Pre-submission data management & controls
  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Customizable training certificate
  • FDA presentation about data quality and fraud:  Steve Wilson, FDA Regulatory Perspective – Data Integrity
  • FDA presentation on auditing clinical data:  Jean Toth-Allen, Auditing Clinical Data
  • FDA presentation on case report tabulation submissions:  Randy Levin, Future of Case Report Tabulation Submissions
  • EMA guidance document on handling missing clinical data
  • EMA guidance on clinical trial site data maintenance
  • Multiple FDA warning letters

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download

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