From ff775edfe3acb8eab63deae5296c4ff24cf4d485 Mon Sep 17 00:00:00 2001 From: borja Date: Thu, 5 Dec 2024 15:20:41 +0100 Subject: [PATCH] Auto saved by Logseq --- journals/2024_12_05.md | 4 +++- 1 file changed, 3 insertions(+), 1 deletion(-) diff --git a/journals/2024_12_05.md b/journals/2024_12_05.md index 40a6e1fb..2b758233 100644 --- a/journals/2024_12_05.md +++ b/journals/2024_12_05.md @@ -25,6 +25,7 @@ - ### A tratar - **WP1: Non cost extension Liconsa**. Based on the timelines for the clinical trial. We need to ask EDCTP for a non cost extension. Delays in regulatory approval - **WP1: Regulatory aspects.** + - **WP5: PQ at WHO.** - ### Notas - AK: We wont get everythinig clear before june 2026, therefore the non cost extension will be starting to discuss with Ana Duarte (project officer at EDCTP). For all to be clear, all info that pertains to WP3,4 and 5. All info that is needed should be ready by july august 2025. The main reason is to have wp2 finishing al the activities related to the visit on month eleven and everything related to closing the clinical trial. For how long? 6 or 12 months? - JM: STOP already needed that and was extended to 5 (it was 4 before). We need to know that they can stretch the budget on site. EDCTP is quite flexible in providing the ok, I don't think they'll deny it, but the budget need to allow teams to survive until then. @@ -43,6 +44,7 @@ - JM: We can meet for this forecast a dedicated session? See how many months we need. - AK: That s somehow happening. The team from liconsa and your team are setting the list of activities and laying them in the calendar. Regarding this non-cost extension, your advice and suggestions are welcome. - CV: I'll let you know whenever they tell me anything about this non-cost extension. She confirmed we need to do an ammendment. - - CV: Si todo va bien la preliminary opinion será el [[2025/01/30]]. In kenya still looking for a local agent. Submissions in latam and india + - CV: Si todo va bien la preliminary opinion será el [[2025/01/30]]. In kenya still looking for a local agent. Submissions in latam and india after EMA. + - AB: We're in a good place for PQ. Liconsa was granted the - ### Decisiones - \ No newline at end of file