LogseqFMS/journals/2024_10_16.md

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- # #Tareas
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- # #Eventos
	- TODO 17:30 - 18:00: WP-5 Interactions w WHO @today
	  SCHEDULED: <2024-10-16 Wed>
		- ### A tratar
			- PQ WHO
		- ### Notas
			- [[Ale]]: Some consultations that we got from [[INSUD]] to us. The ASTMH we need to regroup and decide the strategy. The results of EMA are coming. The response to the PQ office. NTD department is center stage to anything to happen with PQ. Failure to connect with Jonathan and Denise. Put all our resources to have encounter to NTD department. Thats basically it.
			- [[Julie]]: I think with the PQ I think I could do direct outreach. Jonathan is aware about it. Denise probably not aware about the need of the EoI. That direct like will be the best strategy to put this forward.
			- [[Ale]]: Does it need any formal thing the EoI?
			- [[Julie]]: I'm not sure, probably only a communication from the team about the. They're overworked so we need the team to allocate time.
			- Ale: Maybe it's enough if Jonathan speaks about it?
			- [[Alan]]: Its a public statement. It needs to be a public call. There is a formal document. Specially to rationalize. How do you get it written (the EoI). Its the right time because they do it once a year. What goes is very important. We need to make sure we get.
			- [[Ale]]: The essential medicines list is it independent or part of it?
			- [[Alan]]: Careful raising it already. It's tied to dosing. First the pq piece.
			- [[Ale]]: EML aside de momento. aunque se lo podemos colar en plan informal.
			- Ale: THey are very itnerested in what we'red oing. Involve a Denise y Jonathan.
			- [[Carla Valriberas]] : We had this meeting. We let them know anything from our side.
			- [[Julie]]: Theres a whole lot to get everything together. When they're looking for PQ, they probably overlap a lot but don't know if the format is the same.
			- [[Alan]]: El draft? quién lo manda? nuestro regulatory mejor no. Timing. Stewardship agenda.
			- [[Ale]]: Draft and interaction with [[WHO]].
			- [[Alan]]: I suspect we want to target Jonathan, Denise and Maria. Message around that things are ongoing and set a time to coming back and talking about the project. Not about meeting them all the time, but when we're in important stage gates so they're in the loop. Good idea when [[EMA]] is finalized. What's the process and the timeline and how do we handle the different variants. Two main questions to ask for timing.
			- [[Ale]]: We need to understand the 9 and 8mg [[ivm]] are still in development. Are far from where the [[FDC]] is. But I think having them in the visual field might work in our benefit. Also, to see what the reaction is to those two products.
			- [[Alan]]: Lets think [[ivm]]. If it's never going to be a commercial product it doesn't make sense to bring it on. We need to get their trust. It would be beneficial for the company to see if they have something in their goals to mean that 9mg and 18mg make sense beyond [[public health]].
			- [[Ale]]: What do [[WHO]] wwant and need from us? They put our fdc similar to the triple thearpy for LF, but our project is very different.
			- [[Julie]]: First off, they may all want to agree on the answer. I don't think it's wrong to have all three of them. Take off 9mg and 18mg at the time. We want to move forward on the PQ but we need you to move in terms of EoI. Tell them.
			- [[Ale]]: Ponerlas sería un risk que les guste y que advocate por que sean un producto que entre primero y pasen de la [[FDC]].
			- Alan: General feedback about the project. Its ok to ask because wp2 we're notifying, we're too far to ask for feedback, but when we have a draft for wp4 protocol?
		- ### Decisiones
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