Project Team and

Launch Team


Target of Project Team and Launch Team
Project Teams are lead by GD-PLM
Aim to have Marketing Authorizations from the relevant
countries and finished manufacturing process validation
Launch Teams are lead by SpP Business:
Aim to launch the product


Project Team and Launch Team
Project Team
Launch Team
MAA submission
Project Planning:
G1 decision
Project Closure:
G3-4 decision
Time
AFTER G2 DECISION:
Business delegate start to
fill in SpP infotable
Regulatory expert will fill in
planned submission date
Regulatory expert will copy
the patent check status from
PPR to the infotable
AFTER SUBMISSION:
Regulatory expert will inform actual submission
date to Project Team and Launch Manager
Regulatory Expert will update SpP Infotable
(actual submission date)
LAUNCH TEAM:
Project Manager is responsible for information transfer to
launch team (eg. first launch team meeting).
Project Manager is responsible for process validation timing.
The timing of process validation depends on launch schedule.
Project Execution:
G2 decision