Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018

  • 2018
  • Dubai, United Arab Emirates

Description

Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018 is a course that covers topics such as:

  • Impact of the eCTD on regulatory processes and procedures
  • Overview of eCTD readiness at the agencies
  • ECTD compilation and life cycle management
  • Practical experience of submitting an eCTD in the EU and GCC
  • Regulatory strategy facing technical issues
  • Document granularity and readiness
  • Specifications and standards versus regions and procedures

Building the eCTD: Practical Approaches to Compiling Electronic Submissions 2018 brings together attendees with responsibilities in:

  • Dossier Management
  • Regulatory Affairs
  • Data Management
  • Document Management
  • Electronic Publishing/Submissions
  • Compliance
  • Medical Writing
  • IT/IS EDMS
  • Regulatory Affairs Agency eSubmission processing and review

Past Events

Important

Please, check "Building the eCTD: Practical Approaches to Compiling Electronic Submissions" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Pharma

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