E-Submissions & Data Standards for FDA (eCTD, CDISC, HL7)

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Jul 06, 2017
90 minutes
Product Description

The Use of FDA’s Data Standards Program and E-Submissions


FDA’s data standards program enables FDA to streamline and modernize the review process. They also help get everyone in the medical product process speaking the same language. Data standards are like sheet music. Without standard notes, breaths and parallel lines, it does not make sense. Data standards are the scientific parallel allowing everyone to sing the same tune. FDA’s 21st century initiatives include the collaboration of FDA and other organizations to come up with a set of industry standards that can streamline reviews and accelerate submission outcomes.

Some data standards, e.g. structured product labeling, have been required for years. Some standards are new. Starting in May 2017, regulatory submissions to CDER and CBER, have to be made in eCTD format. FDA is also standardizing the electronic submission of study data. Eventually, FDA will have standards for areas such as Identification of Medicinal Products, Pharmaceutical Quality, Manufacturing and more.

The method for sending submissions to the FDA differs based on the Center and submission type being transmitted. This session by expert speaker Angela Bazigos will explain the different standards that are used, what they are used for, and how they affect your company. The session will cover FDA’s electronic submission gateway and will alert you regarding some of the problems that are seen with electronic data submissions. Finally, the session will discuss some of the new requirements for electronic submissions to FDA and what you can expect in the future.

Session Highlights:

  • The problem
  • The solution
  • What are the different standards and how are they used:
    • eCTD
    • CDISC
    • HL7
    • Other standards
  • FDA’s electronic submission gateway
  • Top 10 issues with data
  • Next steps

Who Should Attend?

  • Management (pharma, biotech)
  • Policy analysts
  • Government officers
  • Health IT managers and analysts
  • Research and development (pharmaceutical, academia)
  • Regulatory affairs personnel
  • Quality assurance/quality control personnel
  • Auditors and inspectors
  • Entrepreneurs investors
  • Consultants
  • Regulators

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Angela Bazigos - Pharma Conferences

CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA, MIS Director....   More Info
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