Harmonization Conference phase

Content

DESCRIPTION

  • This is the first phase of the feasibility study process and serves for feasibility study preparation.
  • It is used for the cases where all the participants should know the dossier content (e.g. timetable-related meetings and conferences) because it is visible for all the involved agencies, including IMs.
  • When you start the feasibility process at the Harmonization Conference phase, you cannot add PaPs to your dossier, you have to return to Harmonization to add it.

POSSIBLE TRANSITIONS

Possible transitions diagram from Harmonization Conference in the Feasibility Study Process

Transition list

  • Harmonization Conference -> Feasibility Study Request
    • Who: Leading Applicant
    • Restrictions:
      • All Applicant lights in green or yellow
      • Mandatory fields and IM parameters are fulfilled
  • Harmonization Conference -> Harmonization
    • Who:
      • Leading Applicant
        • Restrictions: None
      • Leading IM
        • Restrictions: None
      • PCS system (Automatic promotion)
        • Restrictions
          • At least one Applicant light is in red or blue
          • Applied the day after the dossier got into the Harmonization Conference phase
  • Harmonization Conference -> Feasibility Elaboration Conference
    • Who: PCS system (Automatic promotion)
    • Restrictions:
      • All Applicant lights in green or yellow
      • Mandatory fields and IM parameters are fulfilled
      • Only promoted if the dossier remains in Harmonization Conference after the second part of January (Please check PCS Calendar for the exact dates)

PERMISSIONS

  • Leading Applicant
    • Read and write access to its own section
  • Applicants
    • Read and write access to their own sections
  • Leading IM
    • Read and write access to its own section
  • IMs
    • Read and write access to their own sections

OTHER DETAILS

  • In this phase, all the data is shared.
  • If dossier should run through the feasibility study, all the required data should be consulted, recorded and harmonized.
  • If any Applicant disagrees its light should be on red to avoid the feasibility study request.
  • Automatic back to harmonization for no activity
    • The deadline of 8/15 days of no activity causing an automatic transfer from Harmonization Conference to Harmonization is switched off for about a week in January (Please search for "PCS process guidelines (year)" for the exact details)