e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013

  • 07 May 2013
  • Webinar

Description

e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013 is a webinar that covers topics such as:

  • Health Level 7 Regulated Clinical Research Information Management
  • Submission Requirements & Guidances, FDA
  • Overview: Approval Process for Drugs, Biologics and Devices
  • E-Submissions, EMEA, EU and globally
  • Electronic Regulatory Submission & Gateway, FDA
  • Electronic Common Technical Document (eCTD), ICH
  • International Conference on Harmonization (ICH)
  • ECTD Guidance and Specifications, FDA
  • Biomedical Research Integrated Domain Group(NIH, FDA, CDISC, HL7)
  • Clinical Data Interchange Standards Consortium, (SDTM, SEND, ADAM)
  • Benefits and Challenges with Data Standards worldwide

e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) 2013 brings together:

  • Policy analysts
  • Management (Pharma, Biotech)
  • Health IT Managers and Analysts
  • Government officers
  • Regulatory Affairs personnel
  • Research and Development (Pharmaceutical, Academia)
  • Auditors and inspectors
  • Quality assurance/quality control personnel
  • Entrepreneurs Investors

Past Events

Important

Please, check "e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7)" official website for possible changes, before making any traveling arrangements

Event Categories

Education: Training
Health & Medicine: Medical technology, Pharma
Science: Biochemistry, Life Sciences & Biology

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