CRED Project Management for Regulatory Affairs Professionals

Example GANTT Chart

Task No. Activity

Duration (Days)

DPB

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

1 KO Meeting

1 1 2

2 Clinical Sub Team Meeting 3 Medical Writing Provide CSRs 4 Author CO Addendum 6 Safety Sub Team Meeting 7 SB and Literature Search 8 Author Safety Report 9 Senior Management Approval 10 CMC Assess Current Data 11 Update Relevant M3 Sections

1 3 4 1 6 8

10

1 5

10

2 1 5

4,8

1

10

12 Author Response Document to CHMP Questions

12 3,7,11

13 Update EN Labels 14 Update EU Nat Labels 15 Author Cover Letter

2 5 5

9,12

13 12

16 Publishing

20 4,8,12,13,14,15