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43 lines
3.2 KiB
Markdown
43 lines
3.2 KiB
Markdown
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- # #Tareas
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- DONE REUNIÓN [[STOP2030/Steering Comittee/2024-10]]
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SCHEDULED: <2024-10-03 Thu>
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- ### A tratar
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- Milestones and deliverables.
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- EDCTP reporting
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- Interim report
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- FDC registration plans
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- ### Notas
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- Alan pide retrasar un mes el White Paper sobre sustainable supply and financing model
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- Tenemos que mirar todos los due dates de nuestros deliverables y ofrecer fechas alternativas en caso de que haga falta retrasarlos
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- En enero empezamos el financial oficial report. Enviaré un email y todo el mundo tiene que enviar a Liconsa (a Carla) para compilar todo el budget disponible.
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- Interim report: cada partner tiene que enviar las cosas en noviembre o diciembre de 2024 para enviar en enero a EDCTP por parte de Liconsa. Hay que hacer un recuento narrativo del trabajo que se ha hecho al respecto.
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- My proposal is
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- Timelines and progress for the REALISE study
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- Habla Jose Muñoz.
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- Regulatory status:
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- For SERU (IRB) we're waiting for the final aproval. expected by the end of september. Submission to PPB and Nacosti (la otra agencia)
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- Ghana: final authorization from Ghana is expected very soon.
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- Protocol amendment: Our hope is having everything ready before the end of the year.
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- Pretrail qualification visits done.
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- Se debería fabricar todo entre octubre y noviembre.
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- Kenia: not before end of feb. 2025 Ghana: nov 2024.
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- Data management plan: end of year. I'm working on it, a little bit slow because we were con el tema de PQ visit y nosequé. End of the year para tener el data management plan.
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- Ale dice que es el clinical data management. El documento está written y ahora tenemos que actualice what is done. For the CRF.
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- Steve:; the -80 ºC storage is being solved. All very positive.
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- WP4. Proponemos 2 arm study comparing acceptability and feasibility of FDC versus ALB.
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- Requirements: FDC aprobada. Readiness of country (de dónde viene la FDC). Recomendan hacerlo después de un exitoso REALISE y aprobación. Que esté listo para ERC el 30 de noviembre? pero queremos que esté la FDC registrada ANTES de enviarlo.
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- En EMA que expect to get more queries from EMA en Oct. We have 1 month. If everything goes well we'll get the preliminiary opinion en Dec.
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- A Ghana se mandó en June. Seems to be 6 month approval. FDA seems to be 6 months.
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- In Kenya we're trying to find the best way to submit the dossier. We're exploring and trying to do it as fast as we can.
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- Once we get EMA approval we might send to CL, CO, EC, PE and Brasil, and India.
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- Vamos a pedirle al departamento de NTD de WHO que se lancen a pedir la inclusión en la lista de medicamentos esenciales. Moxidectin está en el mismo sitio.
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- ASTMH: Coordinated by Stella and
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- Mayor landmark yesterday. Painful process: We tried with a very high impact journal. ALIVE trial accepted for publication in Lancet Infectious Diseases. Good news.
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- Request the manuscript.
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- Ghana got a stop to prepare in ASTMH
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- Status of moxidectin: 45 minute presentation. access and supply issues. Helpful to llisten to because they work a similar path.
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- 70cts and 1dollar as the highest.
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- ### Decisiones
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