260601 PMO alignment

Kekahi

• Speaker 1 0:01
• Speaker 2 0:15
• Speaker 3 0:00
• Speaker 4 0:01
• Speaker 5 2:29

1. 0:00

   Kahua 1: Very good. 149s · Speaker 3

   Very good. Thank you. We are nearly there with the responses. Take that as a positive. Hi, Ellie. Good morning. I can see your screen. Thank you. This is the agenda for today. The first product is the RSV. I think I already shared for this …

2. 2:29

   Kahua 2: yes, right. 77s · Speaker 5

   yes, right. Yes. So this is the starting time and this is the end time. So should we notify TOE for this end time, end point? Which particular study, sorry? It's the opening part of stability. We don't have to actively notify them, dependin…

3. 3:47

   Kahua 3: Okay. Okay, thank you. 302s · Speaker 4

   Okay. Okay, thank you. For RSV, the second agenda is name change. So this year is already released. So we will apply the name. Is this the one that changed from gold to gold colloid? Yes. Okay. Ellie, I'm sorry. When I read that email the o…

4. 8:50

   Kahua 4: There's at least two deficiency rounds that we always expect and we can still make these changes in line with that. 302s · Speaker 3

   There's at least two deficiency rounds that we always expect and we can still make these changes in line with that. So my recommendation would still be to proceed with our approval chain because we've been delayed many times now and we cann…

5. 13:52

   Kahua 5: and maybe early that would be better, right? 301s · Speaker 2

   and maybe early that would be better, right? Time the CRB board in line with our submission so that that week that we're submitting, this is on the agenda for the CRB board. Then you have approval for the CR that is raised. after we submitt…

6. 18:53

   Kahua 6: procedure is not being followed. 102s · Speaker 1

   procedure is not being followed. I think they need to get ahead of it to make sure that there isn't a scenario like this in Road to Adina. Because I see a lot of arguments being made for the way things were procured during the design verifi…

7. 20:35

   Kahua 7: Oh, actually, I couldn't think about the QI, but just in my perspective, I just want to suggest just including the equali and. 302s · Speaker 3

   Oh, actually, I couldn't think about the QI, but just in my perspective, I just want to suggest just including the equali and. we can response why we don't need to mention the approved supplier for E .coli because that is not our animal. Ou…

8. 25:38

   Kahua 8: sent saying that there's procedure 310. 71s · Speaker 1

   sent saying that there's procedure 310. says that materials used in design verification and validation are not part of the proposed medical device design may be purchased from suppliers, not ASL, we're really going to struggle to justify th…

9. 26:49

   Kahua 9: Well, the answer is it's not a material used in a pre -step. 158s · Speaker 3

   Well, the answer is it's not a material used in a pre -step. Our manufacturing process in our technical file says that these materials are used in a major step in production. So that means you cannot use SDC 310 as an argument to say we don…