Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. HC is expected to have full implementation of ICH Q12 by late 2022. Following data collection, the authoring and submission process begins as described in Figure 2, which could take a minimum of three months to complete. Trudy Patterson.
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