Planning KMS and BD
Category: Other
Updated: 4 Nov 2019
Contributors
Created byRoberta Rossi
Attachments
Events
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meeting 28 Novplaceholder
meeting 9 Decteam
meeting 30 Janteam
meeting 9 Janconsolidation
meeting 25 Febconsolidation
meeting 12 Marconsolidation
meeting 2 AprMRL & BD
Submission
10 Maypre-IND meeting
10 July (+60d)Periods
KMS review & endorse
for Preclinical, Tox, TRD, RA
7 Nov -13 DecNext Level
22-28 Nov (5d)Senior M quest approval
4-9 Dec (4d)MRL & BD
1st rev cycle
Next Level
10-20 Feb (9d)1st review
consolidation
20 - 28 Feb (7d)MRL & BD
2nd rev cycle
Next Level
28 Feb-10 Mar (8d)2nd rev
consolidation
11-17 Mar (5d)MRL & BD
Senior M
approval
18-24 Mar (5d)SM Consolidation
25 Mar-31 Mar (5d)MRL&BD
final approval
+ full packagePublishingpre-IND preparation 6 monthsKMS review + Clinical
28 Nov - 10 Feb 2020KMS
Next L review Clinical
10-13 Feb (3d)
+ Senior M
approval
14-18 Feb (3d)Grouping
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