MedTech I.Q.

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eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.  This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Anyone responsible for providing content for the CTD

eCTD Prepararation

  • Technical requirements for an eCTD submission
  • Document naming requirements
  • Building the folder structure
  • Publishing each document, module & submission
  • Tools for tracking and managing eCTD content
  • Performing quality checks on the eCTD
  • Lifecycle management: Updating content (amendments, supplements, variations, etc.)

http://bit.ly/2QXEXwr

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