2026-07-15 short PMO

Jul 15, 2026 08:16 · 8:27 · English · Whisper Turbo · 4 Relatori
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0:00
S… Speaker 3 (2026-07-15 short PMO)
So I think,
0:02
S… Speaker 3 (2026-07-15 short PMO)
I expect tomorrow we will have a meeting
0:07
S… Speaker 3 (2026-07-15 short PMO)
for the
0:10
S… Speaker 3 (2026-07-15 short PMO)
implementation CR for Shagas.
0:13
S… Speaker 3 (2026-07-15 short PMO)
But I don't have any updating after
0:18
S… Speaker 3 (2026-07-15 short PMO)
the email,
0:19
S… Speaker 3 (2026-07-15 short PMO)
like which CR can be followed to follow
0:23
S… Speaker 3 (2026-07-15 short PMO)
on project.
0:24
S… Speaker 3 (2026-07-15 short PMO)
So is there any update or can I use the submission CR for
0:28
S… Speaker 3 (2026-07-15 short PMO)
follow on projects?
0:31
S… Speaker 1 (2026-07-15 short PMO)
I think you have to discuss and decide
0:35
S… Speaker 1 (2026-07-15 short PMO)
at ADK which each one is better,
0:38
S… Speaker 1 (2026-07-15 short PMO)
right?
0:38
S… Speaker 1 (2026-07-15 short PMO)
I'm kind of in two minds.
0:42
S… Speaker 1 (2026-07-15 short PMO)
On the one hand,
0:43
S… Speaker 1 (2026-07-15 short PMO)
I understand why we want to be closing.
0:45
S… Speaker 1 (2026-07-15 short PMO)
We've got certification.
0:47
S… Speaker 1 (2026-07-15 short PMO)
It's just a strange situation.
0:49
S… Speaker 1 (2026-07-15 short PMO)
We've got certification,
0:50
S… Speaker 1 (2026-07-15 short PMO)
but we have a follow -on project.
0:52
S… Speaker 1 (2026-07-15 short PMO)
My only concern is that how
0:57
S… Speaker 1 (2026-07-15 short PMO)
are we documenting
0:59
S… Speaker 1 (2026-07-15 short PMO)
the follow -on project.
1:00
S… Speaker 1 (2026-07-15 short PMO)
For me, it almost feels cleaner to close
1:04
S… Speaker 1 (2026-07-15 short PMO)
change actions against the deficiency round,
1:07
S… Speaker 1 (2026-07-15 short PMO)
because the deficiency round is officially closed,
1:10
S… Speaker 1 (2026-07-15 short PMO)
and opening up something new for the follow -on project,
1:13
S… Speaker 1 (2026-07-15 short PMO)
because it is something that,
1:15
S… Speaker 1 (2026-07-15 short PMO)
in a way,
1:17
S… Speaker 1 (2026-07-15 short PMO)
is independent.
1:18
S… Speaker 1 (2026-07-15 short PMO)
So it's,
1:20
S… Speaker 1 (2026-07-15 short PMO)
although it's still connected to the status conformity assessment,
1:24
S… Speaker 1 (2026-07-15 short PMO)
the certificate is issued,
1:26
S… Speaker 1 (2026-07-15 short PMO)
but we're doing it.
1:28
S… Speaker 1 (2026-07-15 short PMO)
this extra thing so where do we document the
1:32
S… Speaker 1 (2026-07-15 short PMO)
extra thing and what Patricia was suggesting is more
1:37
S… Speaker 1 (2026-07-15 short PMO)
of a cleaner view from an audit point of view like the
1:41
S… Speaker 1 (2026-07-15 short PMO)
one way we could close everything related to the certification process
1:45
S… Speaker 1 (2026-07-15 short PMO)
because we've completed that we've certified
1:50
S… Speaker 1 (2026-07-15 short PMO)
right but on the other hand we have this
1:53
S… Speaker 1 (2026-07-15 short PMO)
extra follow -on project that is tied to it.
1:56
S… Speaker 1 (2026-07-15 short PMO)
So I suppose you could go either way,
1:58
S… Speaker 1 (2026-07-15 short PMO)
as long as it's documented clearly.
2:01
S… Speaker 1 (2026-07-15 short PMO)
But I also understand from your point of view,
2:04
S… Speaker 1 (2026-07-15 short PMO)
we don't like creating UCR.
2:06
S… Speaker 1 (2026-07-15 short PMO)
I don't think
2:10
S… Speaker 1 (2026-07-15 short PMO)
it's going to be a long time like that.
2:12
S… Speaker 1 (2026-07-15 short PMO)
QMSR should land in the next couple of weeks.
2:16
S… Speaker 1 (2026-07-15 short PMO)
So if we feel that we can document it properly,
2:20
S… Speaker 1 (2026-07-15 short PMO)
I'm okay if we want to just keep it open until
2:24
S… Speaker 1 (2026-07-15 short PMO)
we get the QMS cert issued and then it's
2:29
S… Speaker 1 (2026-07-15 short PMO)
done anyway.
2:30
S… Speaker 1 (2026-07-15 short PMO)
We didn't have to create extra bits because we're also talking about only
2:34
S… Speaker 1 (2026-07-15 short PMO)
another month or so for the follow -on project and that will
2:38
S… Speaker 1 (2026-07-15 short PMO)
be done as well.
2:39
S… Speaker 1 (2026-07-15 short PMO)
So we could weigh the effort against it.
2:44
S… Speaker 1 (2026-07-15 short PMO)
creating a new CR and everything against something that is actually very
2:48
S… Speaker 1 (2026-07-15 short PMO)
short term.
2:49
S… Speaker 2 (2026-07-15 short PMO)
Do you think?
2:50
S… Speaker 3 (2026-07-15 short PMO)
But I think I
2:55
S… Speaker 3 (2026-07-15 short PMO)
just want to make sure what documents need
3:00
S… Speaker 3 (2026-07-15 short PMO)
to the new CR.
3:01
S… Speaker 3 (2026-07-15 short PMO)
I mean, TI and IFU,
3:03
S… Speaker 3 (2026-07-15 short PMO)
maybe they just have own CR for updating?
3:07
S… Speaker 4 (2026-07-15 short PMO)
Well,
3:09
S… Speaker 1 (2026-07-15 short PMO)
you mean if we go the approach of creating a new CR for the following project?
3:16
S… Speaker 1 (2026-07-15 short PMO)
Yeah,
3:17
S… Speaker 3 (2026-07-15 short PMO)
if we make a new CR.
3:19
S… Speaker 1 (2026-07-15 short PMO)
It would be protocols
3:26
S… Speaker 1 (2026-07-15 short PMO)
and reports as well because it's everything to do with that activity.
3:30
S… Speaker 3 (2026-07-15 short PMO)
But as you know,
3:33
S… Speaker 3 (2026-07-15 short PMO)
the event reports and interfering
3:38
S… Speaker 3 (2026-07-15 short PMO)
final reports is already in agile.
3:40
S… Speaker 4 (2026-07-15 short PMO)
See,
3:43
S… Speaker 1 (2026-07-15 short PMO)
but then I do think you have enough here to argue that
3:46
S… Speaker 1 (2026-07-15 short PMO)
due to the short -term nature of this additional project,
3:51
S… Speaker 1 (2026-07-15 short PMO)
we already have enough activity open in Agile to link
3:55
S… Speaker 1 (2026-07-15 short PMO)
it correctly to that.
3:56
S… Speaker 1 (2026-07-15 short PMO)
So if you can make that argument and everybody in the ADK
4:01
S… Speaker 1 (2026-07-15 short PMO)
agrees, we keep this change action open because we have until when?
4:04
S… Speaker 2 (2026-07-15 short PMO)
August,
4:05
S… Speaker 2 (2026-07-15 short PMO)
is it, for this change action?
4:07
S… Speaker 1 (2026-07-15 short PMO)
What's the original date?
4:08
S… Speaker 1 (2026-07-15 short PMO)
I think that's maybe her main concern is that we don't need to
4:12
S… Speaker 1 (2026-07-15 short PMO)
extend it again.
4:13
S… Speaker 3 (2026-07-15 short PMO)
I see.
4:17
S… Speaker 1 (2026-07-15 short PMO)
So if we can get it done before that original one,
4:20
S… Speaker 1 (2026-07-15 short PMO)
I would say,
4:22
S… Speaker 2 (2026-07-15 short PMO)
yes,
4:23
S… Speaker 1 (2026-07-15 short PMO)
you have enough of an argument to suggest let's keep the old change
4:27
S… Speaker 1 (2026-07-15 short PMO)
action open and everything that's already in Agile is connected to this
4:31
S… Speaker 1 (2026-07-15 short PMO)
set of CRs,
4:34
S… Speaker 1 (2026-07-15 short PMO)
et cetera, in Agile.
4:36
S… Speaker 1 (2026-07-15 short PMO)
If we are going to reach the end of that change actions,
4:41
S… Speaker 2 (2026-07-15 short PMO)
due date,
4:42
S… Speaker 1 (2026-07-15 short PMO)
it may become a different conversation,
4:44
S… Speaker 1 (2026-07-15 short PMO)
but I believe you're going to be done in August,
4:47
S… Speaker 1 (2026-07-15 short PMO)
right? So we should be safely finished in time.
4:51
S… Speaker 3 (2026-07-15 short PMO)
I see.
4:53
S… Speaker 3 (2026-07-15 short PMO)
Actually,
4:55
S… Speaker 3 (2026-07-15 short PMO)
we will have a working session tomorrow,
4:58
S… Speaker 3 (2026-07-15 short PMO)
so I can make an agenda for this issue,
5:02
S… Speaker 3 (2026-07-15 short PMO)
and we will discuss.
5:04
S… Speaker 2 (2026-07-15 short PMO)
Have you ever
5:08
S… Speaker 2 (2026-07-15 short PMO)
talked with Ama about this?
5:12
S… Speaker 1 (2026-07-15 short PMO)
So Patricia has just given her input for it.
5:15
S… Speaker 1 (2026-07-15 short PMO)
I have not spoken to Anna specifically about it.
5:18
S… Speaker 1 (2026-07-15 short PMO)
I think at the end of the day,
5:20
S… Speaker 1 (2026-07-15 short PMO)
they'll only just advise you that you can make the decision.
5:24
S… Speaker 1 (2026-07-15 short PMO)
I don't see any reason to insist on one or
5:28
S… Speaker 1 (2026-07-15 short PMO)
the other.
5:29
S… Speaker 1 (2026-07-15 short PMO)
I can see arguments for both sides.
5:30
S… Speaker 4 (2026-07-15 short PMO)
Yeah,
5:32
S… Speaker 2 (2026-07-15 short PMO)
I'm just mentioning Anna because she's on site.
5:35
S… Speaker 2 (2026-07-15 short PMO)
Okay.
5:37
S… Speaker 2 (2026-07-15 short PMO)
So maybe if she's on site...
5:41
S… Speaker 1 (2026-07-15 short PMO)
Why don't you just,
5:43
S… Speaker 1 (2026-07-15 short PMO)
if you see her,
5:44
S… Speaker 1 (2026-07-15 short PMO)
just ask her what the opinion is and explain to her that we've got two options to
5:48
S… Speaker 1 (2026-07-15 short PMO)
go for.
5:48
S… Speaker 1 (2026-07-15 short PMO)
But if you want to keep your current one,
5:51
S… Speaker 1 (2026-07-15 short PMO)
I would suggest you tell her,
5:54
S… Speaker 1 (2026-07-15 short PMO)
look, this is short term.
5:55
S… Speaker 1 (2026-07-15 short PMO)
It's not one of those long term CRs that are opening again.
5:59
S… Speaker 1 (2026-07-15 short PMO)
So it is worth considering the effort of a
6:03
S… Speaker 1 (2026-07-15 short PMO)
new CR versus ONIA.
6:06
S… Speaker 1 (2026-07-15 short PMO)
Another six to eight week period that we're waiting for input to
6:10
S… Speaker 1 (2026-07-15 short PMO)
close those actions.
6:11
S… Speaker 4 (2026-07-15 short PMO)
Okay.
6:16
S… Speaker 4 (2026-07-15 short PMO)
Yeah.
6:19
S… Speaker 3 (2026-07-15 short PMO)
And second question is about,
6:22
S… Speaker 3 (2026-07-15 short PMO)
this is our IVA implementation workshop
6:26
S… Speaker 3 (2026-07-15 short PMO)
that will be in next week.
6:28
S… Speaker 3 (2026-07-15 short PMO)
But for preparing,
6:31
S… Speaker 3 (2026-07-15 short PMO)
I just have a question for Cloud Media because
6:35
S… Speaker 3 (2026-07-15 short PMO)
this is a submission part,
6:37
S… Speaker 3 (2026-07-15 short PMO)
but we need to calculate the study.
6:41
S… Speaker 3 (2026-07-15 short PMO)
We need to count the study,
6:43
S… Speaker 3 (2026-07-15 short PMO)
but could we include the cloud media for this
6:48
S… Speaker 4 (2026-07-15 short PMO)
section?
6:49
S… Speaker 3 (2026-07-15 short PMO)
Or exclude it?
6:51
S… Speaker 4 (2026-07-15 short PMO)
Because
6:56
S… Speaker 3 (2026-07-15 short PMO)
there is no decision.
6:57
S… Speaker 2 (2026-07-15 short PMO)
If you do,
6:57
S… Speaker 1 (2026-07-15 short PMO)
then you need to put a star next to it with a bit of an explanation that
7:02
S… Speaker 1 (2026-07-15 short PMO)
this is a pending executive decision.
7:05
S… Speaker 4 (2026-07-15 short PMO)
So
7:12
S… Speaker 1 (2026-07-15 short PMO)
if you want to consider it just in case it does come back.
7:16
S… Speaker 1 (2026-07-15 short PMO)
and then that effort and activity needs to be put against it then by
7:21
S… Speaker 1 (2026-07-15 short PMO)
all means included so people know it's not officially off yet but it's
7:26
S… Speaker 1 (2026-07-15 short PMO)
it's a strange one because even even in our own goals right committee is
7:31
S… Speaker 1 (2026-07-15 short PMO)
still forced to perform part of that submission goal to have all IVDR products submitted by the
7:35
S… Speaker 1 (2026-07-15 short PMO)
end of this year
7:37
S… Speaker 1 (2026-07-15 short PMO)
Even if they suddenly go today,
7:39
S… Speaker 1 (2026-07-15 short PMO)
which will not happen,
7:40
S… Speaker 1 (2026-07-15 short PMO)
yes,
7:41
S… Speaker 1 (2026-07-15 short PMO)
proceed with chlamydia,
7:42
S… Speaker 1 (2026-07-15 short PMO)
there's no way we can get that done in time because of all the work and effort required,
7:46
S… Speaker 1 (2026-07-15 short PMO)
right? I think it's highly unlikely
7:50
S… Speaker 1 (2026-07-15 short PMO)
that this product continues,
7:52
S… Speaker 1 (2026-07-15 short PMO)
but it's doing the rounds
7:56
S… Speaker 1 (2026-07-15 short PMO)
through the marketing debates,
7:57
S… Speaker 1 (2026-07-15 short PMO)
like many other topics,
7:59
S… Speaker 1 (2026-07-15 short PMO)
the marketing debates at the moment.
8:01
S… Speaker 3 (2026-07-15 short PMO)
Okay.
8:02
S… Speaker 4 (2026-07-15 short PMO)
Okay.
8:04
S… Speaker 4 (2026-07-15 short PMO)
Actually,
8:06
S… Speaker 3 (2026-07-15 short PMO)
that's all for my question.
8:13
S… Speaker 1 (2026-07-15 short PMO)
Okay.
8:13
S… Speaker 3 (2026-07-15 short PMO)
Thank you.
8:14
S… Speaker 2 (2026-07-15 short PMO)
Thank you for your...
8:15
S… Speaker 2 (2026-07-15 short PMO)
Is that it?
8:17
S… Speaker 1 (2026-07-15 short PMO)
Yeah.
8:17
S… Speaker 2 (2026-07-15 short PMO)
Yes.
8:18
S… Speaker 2 (2026-07-15 short PMO)
Thank you for your time.
8:21
S… Speaker 3 (2026-07-15 short PMO)
Thank you.
8:22
S… Speaker 1 (2026-07-15 short PMO)
You're welcome.
8:22
S… Speaker 2 (2026-07-15 short PMO)
Let's pick you again soon.
8:24
S… Speaker 2 (2026-07-15 short PMO)
Bye.
8:25
S… Speaker 2 (2026-07-15 short PMO)
Bye.

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