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December 15, 2019
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Planning KMS and BD
Создана
Roberta Rossi
⟶ Обновлено 1 мес назад ⟶
List of edits
Комментарии
События
placeholder meeting 28 Nov
placeholder meeting 9 Dec
team meeting 30 Jan
team meeting 9 Jan
consolidation meeting 25 Feb
consolidation meeting 12 Mar
consolidation meeting 2 Apr
MRL & BD Submission 10 May
pre-IND meeting 10 July (+60d)
Периоды
KMS review & endorse for Preclinical, Tox, TRD, RA 7 Nov -13 Dec
Next 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 package
Publishing
pre-IND preparation 6 months
KMS review + Clinical 28 Nov - 10 Feb 2020
KMS Next L review Clinical 10-13 Feb (3d) + Senior M approval 14-18 Feb (3d)
Группировать
Периоды
Draft MRL /BD with questions agreed/final
