Sunday, February 14, 2010

Creating a Project Planner for your eCTD Submission

Pharma companies have awareness and knowledge with respect to "what it takes" to file an eCTD for their drug with FDA. To aid in the overall project planning and eCTD organization and to ensure that the file is complete when you press "send" to FDA - a Project Planner is strongly advised to help manage the overall file and deliverable. Creation of a user friendly, accurate, Project Planner for an eCTD submission, pharma functions, CROs and team members must consider the following "initial" points:

  • task involved
  • resources required
  • capacity required
  • team composite
  • team leadership
  • issue management
  • process and procedure
  • function responsibility
  • CRO responsibility
  • team accountability
  • CRO accountability
  • estimated hours per task
  • estimated number of drafts per task
  • estimated overall timeline per task
  • estimated "start/"stop" dates per task
  • therapeutic indication and claim
  • new chemical entity
  • brand
  • generic
  • typical or atypical eCTD organization, backbone structure
  • special SAEs and how to handle and adjudicate
  • interlinking data and documentation to legacy and previously submitted materials to FDA
  • estimated date of "expected" eCTD filing
  • estimated date of "realistic" eCTD filing
  • correspondence and agreements with FDA pertaining to the eCTD Submission Table of Contents.

Creating a proper Project Planner that realistically addresses task and time is not a one day event. It takes team integration and communication, starting with initial, simple questions and resources while taking into consideration results from preclinical and clinical studies and how to handle serious adverse events of interest.

Above are initial points to consider. More to come...

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