260602 Touchpoint

Jun 02, 2026 08:54 · 31:48 · English · Whisper Turbo · 7 Дыбыс тақшалары
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0:31
S… Speaker 2 (260602 Touchpoint)
I'll just give it a minute to see if anyone else joins.
0:34
S… Speaker 1 (260602 Touchpoint)
So
0:57
S… Speaker 1 (260602 Touchpoint)
in the meantime,
0:57
S… Speaker 1 (260602 Touchpoint)
we have submitted Chagas deficiency round one
1:02
S… Speaker 1 (260602 Touchpoint)
yesterday,
1:03
S… Speaker 1 (260602 Touchpoint)
just yesterday.
1:04
S… Speaker 1 (260602 Touchpoint)
Congratulations.
1:06
S… Speaker 2 (260602 Touchpoint)
Thank you everyone for your hard work on that.
1:09
S… Speaker 2 (260602 Touchpoint)
We had a lot of to and fro on getting many of
1:14
S… Speaker 2 (260602 Touchpoint)
those responses resolved,
1:15
S… Speaker 2 (260602 Touchpoint)
but that's finally in now and hopefully the second
1:19
S… Speaker 2 (260602 Touchpoint)
round will be much more and easier to resolve then.
1:26
S… Speaker 2 (260602 Touchpoint)
And I think we probably have enough folks on the line to get
1:30
S… Speaker 2 (260602 Touchpoint)
started.
1:30
S… Speaker 2 (260602 Touchpoint)
I'm sure the rest can join as we go.
1:33
S… Speaker 2 (260602 Touchpoint)
If you want to go ahead,
1:34
S… Speaker 2 (260602 Touchpoint)
please. Yes.
1:35
S… Speaker 1 (260602 Touchpoint)
So for our today's
1:39
S… Speaker 1 (260602 Touchpoint)
agenda, unfortunately,
1:42
S… Speaker 1 (260602 Touchpoint)
Yoo Kyung is out of office today.
1:45
S… Speaker 1 (260602 Touchpoint)
So I will handle the RSV and Charlotte's also soon.
1:49
S… Speaker 1 (260602 Touchpoint)
Let's have a begin.
1:52
S… Speaker 1 (260602 Touchpoint)
For RS3,
1:54
S… Speaker 1 (260602 Touchpoint)
we have a gap study as a free cell
1:59
S… Speaker 1 (260602 Touchpoint)
study and the negative sample will arrive at October.
2:03
S… Speaker 1 (260602 Touchpoint)
Our
2:08
S… Speaker 1 (260602 Touchpoint)
report for the gap study
2:12
S… Speaker 1 (260602 Touchpoint)
will be ready
2:16
S… Speaker 1 (260602 Touchpoint)
at November.
2:36
S… Speaker 2 (260602 Touchpoint)
I assume you've mapped that back into the trials
2:41
S… Speaker 2 (260602 Touchpoint)
tracker you have a timeline that you've shown before.
2:44
S… Speaker 1 (260602 Touchpoint)
So,
2:45
S… Speaker 1 (260602 Touchpoint)
no, no, no.
2:46
S… Speaker 1 (260602 Touchpoint)
This rose up in internal ADK
2:50
S… Speaker 1 (260602 Touchpoint)
working session and TO OMS said
2:55
S… Speaker 1 (260602 Touchpoint)
the GAP study report will be ready until November.
3:02
S… Speaker 1 (260602 Touchpoint)
from just before that's that rose of just
3:07
S… Speaker 1 (260602 Touchpoint)
before so that's a new news okay so yes and
3:11
S… Speaker 1 (260602 Touchpoint)
and name of critical materials
3:15
S… Speaker 1 (260602 Touchpoint)
today we don't have adk da team here
3:19
S… Speaker 1 (260602 Touchpoint)
but uh we just talked about uh
3:24
S… Speaker 1 (260602 Touchpoint)
the
3:25
S… Speaker 1 (260602 Touchpoint)
planning to update those critical material name in
3:29
S… Speaker 1 (260602 Touchpoint)
the deficiency round two so that we
3:34
S… Speaker 1 (260602 Touchpoint)
are planning to make an
3:39
S… Speaker 1 (260602 Touchpoint)
update in deficiency round
3:43
S… Speaker 1 (260602 Touchpoint)
two for is this is for chagas
3:49
S… Speaker 1 (260602 Touchpoint)
i believe
3:52
S… Speaker 2 (260602 Touchpoint)
I think it's probably for both,
3:54
S… Speaker 1 (260602 Touchpoint)
right? Yeah,
3:55
S… Speaker 1 (260602 Touchpoint)
yes. Anyway,
3:56
S… Speaker 1 (260602 Touchpoint)
we are trying to have
4:02
S… Speaker 1 (260602 Touchpoint)
trying to reflect this change into deficiency round two
4:06
S… Speaker 1 (260602 Touchpoint)
until we are waiting for their response.
4:09
S… Speaker 1 (260602 Touchpoint)
But there was a concern from ADKDA
4:14
S… Speaker 1 (260602 Touchpoint)
that we don't have to work twice.
4:17
S… Speaker 1 (260602 Touchpoint)
So that's what I had worried
4:22
S… Speaker 1 (260602 Touchpoint)
about yesterday.
4:23
S… Speaker 1 (260602 Touchpoint)
So that's the exact one.
4:27
S… Speaker 1 (260602 Touchpoint)
DA was worried,
4:29
S… Speaker 1 (260602 Touchpoint)
has a concern that they might have
4:34
S… Speaker 1 (260602 Touchpoint)
the same work twice.
4:36
S… Speaker 1 (260602 Touchpoint)
So that means they have to make approval
4:40
S… Speaker 1 (260602 Touchpoint)
of all MDF,
4:43
S… Speaker 1 (260602 Touchpoint)
IFUs and STAT for twice.
4:46
S… Speaker 1 (260602 Touchpoint)
So they suggest to update those
4:50
S… Speaker 1 (260602 Touchpoint)
names of critical materials after the
4:54
S… Speaker 1 (260602 Touchpoint)
deficiency feedback.
4:57
S… Speaker 1 (260602 Touchpoint)
comes so we
5:00
S… Speaker 2 (260602 Touchpoint)
or planning to update our critical
5:05
S… Speaker 2 (260602 Touchpoint)
raw material name in...
5:07
S… Speaker 1 (260602 Touchpoint)
June,
5:08
S… Speaker 2 (260602 Touchpoint)
so waiting for the July's
5:12
S… Speaker 2 (260602 Touchpoint)
response.
5:13
S… Speaker 2 (260602 Touchpoint)
So that was our original plan,
5:17
S… Speaker 2 (260602 Touchpoint)
but DA has a concern that they may have
5:21
S… Speaker 2 (260602 Touchpoint)
to work twice,
5:23
S… Speaker 2 (260602 Touchpoint)
so it will be better to update,
5:27
S… Speaker 2 (260602 Touchpoint)
reflect the update after the deficiency round comes.
5:33
S… Speaker 2 (260602 Touchpoint)
Now we have a concern about this cut up date.
5:37
S… Speaker 2 (260602 Touchpoint)
So this is so we have no buffer at all.
5:40
S… Speaker 2 (260602 Touchpoint)
So that's my
5:45
S… Speaker 2 (260602 Touchpoint)
concern right now.
5:48
S… Speaker 1 (260602 Touchpoint)
OK,
5:49
S… Speaker 1 (260602 Touchpoint)
so if you just go back to that timeline.
5:54
S… Speaker 1 (260602 Touchpoint)
If we think about this change request,
5:57
S… Speaker 1 (260602 Touchpoint)
this is for all three of these products,
5:59
S… Speaker 1 (260602 Touchpoint)
am I correct?
5:59
S… Speaker 1 (260602 Touchpoint)
Yes.
6:00
S… Speaker 1 (260602 Touchpoint)
Just to make that name change.
6:02
S… Speaker 1 (260602 Touchpoint)
So we have to try and find the most efficient way,
6:06
S… Speaker 1 (260602 Touchpoint)
therefore timing,
6:08
S… Speaker 1 (260602 Touchpoint)
to apply that change.
6:10
S… Speaker 1 (260602 Touchpoint)
RSV,
6:12
S… Speaker 1 (260602 Touchpoint)
we are waiting for a second round efficiency,
6:15
S… Speaker 1 (260602 Touchpoint)
which should arrive.
6:16
S… Speaker 1 (260602 Touchpoint)
Any day now.
6:17
S… Speaker 1 (260602 Touchpoint)
And Shagas,
6:19
S… Speaker 1 (260602 Touchpoint)
we've just gone back with round one.
6:22
S… Speaker 1 (260602 Touchpoint)
So round two can be expected in the next,
6:25
S… Speaker 1 (260602 Touchpoint)
I would say,
6:26
S… Speaker 1 (260602 Touchpoint)
four to eight weeks.
6:28
S… Speaker 1 (260602 Touchpoint)
Rota,
6:29
S… Speaker 1 (260602 Touchpoint)
Dina, we are in a critical chain for
6:33
S… Speaker 1 (260602 Touchpoint)
approval right now.
6:34
S… Speaker 1 (260602 Touchpoint)
So we cannot bring things back and restart that approval chain because we
6:38
S… Speaker 1 (260602 Touchpoint)
will miss the already delayed.
6:41
S… Speaker 1 (260602 Touchpoint)
submission date of 31 July if we make any other changes.
6:46
S… Speaker 1 (260602 Touchpoint)
So we are going to have to find a way
6:50
S… Speaker 1 (260602 Touchpoint)
And I'm not sure how that is defined in the change
6:56
S… Speaker 1 (260602 Touchpoint)
request.
6:57
S… Speaker 1 (260602 Touchpoint)
Patricia,
6:58
S… Speaker 1 (260602 Touchpoint)
I don't know if you know how it's defined in that change request,
7:01
S… Speaker 1 (260602 Touchpoint)
but I'm assuming that we are saying in the change request that we have identified this
7:05
S… Speaker 1 (260602 Touchpoint)
name change that needs to happen.
7:07
S… Speaker 1 (260602 Touchpoint)
It needs to happen in these documents.
7:09
S… Speaker 1 (260602 Touchpoint)
I don't think it defines by when it needs to happen,
7:12
S… Speaker 1 (260602 Touchpoint)
but I don't see how we are going to be able to make
7:16
S… Speaker 1 (260602 Touchpoint)
all of these changes at the same time.
7:19
S… Speaker 1 (260602 Touchpoint)
My reason for it is this,
7:23
S… Speaker 1 (260602 Touchpoint)
RSV.
7:25
S… Speaker 1 (260602 Touchpoint)
will come in this week or next because it's already overdue,
7:29
S… Speaker 1 (260602 Touchpoint)
that deficiency round.
7:30
S… Speaker 1 (260602 Touchpoint)
We can most definitely update the labels to reflect that
7:34
S… Speaker 1 (260602 Touchpoint)
name change and that would be the place to do it because we would expect
7:38
S… Speaker 1 (260602 Touchpoint)
when we respond to deficiency round two that we will close out
7:42
S… Speaker 1 (260602 Touchpoint)
all deficiencies.
7:43
S… Speaker 1 (260602 Touchpoint)
We do not think it will go to round three.
7:46
S… Speaker 1 (260602 Touchpoint)
We should be able to close it out.
7:47
S… Speaker 1 (260602 Touchpoint)
So that is your last opportunity,
7:50
S… Speaker 1 (260602 Touchpoint)
so to speak.
7:51
S… Speaker 1 (260602 Touchpoint)
to make this change prior to a certificate being issued.
7:54
S… Speaker 1 (260602 Touchpoint)
Shagas,
7:56
S… Speaker 1 (260602 Touchpoint)
we have to now wait for round two.
7:58
S… Speaker 1 (260602 Touchpoint)
So you could get your approval via
8:02
S… Speaker 1 (260602 Touchpoint)
your change request to create the action,
8:06
S… Speaker 1 (260602 Touchpoint)
which is ultimately to update identified labels.
8:09
S… Speaker 1 (260602 Touchpoint)
You can start doing that already in anticipation for
8:13
S… Speaker 1 (260602 Touchpoint)
when deficiency round two lands in four to eight weeks.
8:16
S… Speaker 1 (260602 Touchpoint)
Road to Adena,
8:18
S… Speaker 1 (260602 Touchpoint)
on the other hand,
8:19
S… Speaker 1 (260602 Touchpoint)
cannot be
8:22
S… Speaker 1 (260602 Touchpoint)
cannot be steered off course for 31 July submission now.
8:25
S… Speaker 1 (260602 Touchpoint)
So we cannot go back and make any changes now.
8:29
S… Speaker 1 (260602 Touchpoint)
We have to submit with what we have and then prepare that correction
8:34
S… Speaker 1 (260602 Touchpoint)
for deficiency round one.
8:36
S… Speaker 1 (260602 Touchpoint)
So I don't see how we can do all three of these at the same time.
8:40
S… Speaker 2 (260602 Touchpoint)
So what I mean
8:45
S… Speaker 2 (260602 Touchpoint)
is we don't need to...
8:48
S… Speaker 2 (260602 Touchpoint)
have the changes three of this product at the same time.
8:52
S… Speaker 2 (260602 Touchpoint)
We don't need to do that all simultaneously,
8:56
S… Speaker 2 (260602 Touchpoint)
but what I mean
9:00
S… Speaker 1 (260602 Touchpoint)
is...
9:06
S… Speaker 2 (260602 Touchpoint)
If we update the IFU and EMR
9:10
S… Speaker 2 (260602 Touchpoint)
right now for Shagaz,
9:12
S… Speaker 2 (260602 Touchpoint)
if the deficiency round comes and
9:16
S… Speaker 2 (260602 Touchpoint)
they request for updates from
9:21
S… Speaker 2 (260602 Touchpoint)
IFU or something maybe,
9:23
S… Speaker 2 (260602 Touchpoint)
so we have...
9:26
S… Speaker 2 (260602 Touchpoint)
So the team wants
9:30
S… Speaker 2 (260602 Touchpoint)
to wait whether they request it for IFE update
9:34
S… Speaker 2 (260602 Touchpoint)
or not,
9:35
S… Speaker 2 (260602 Touchpoint)
then we can reflect our changes.
9:38
S… Speaker 2 (260602 Touchpoint)
So that's what they says.
9:40
S… Speaker 1 (260602 Touchpoint)
OK,
9:42
S… Speaker 1 (260602 Touchpoint)
so the approach would be.
9:44
S… Speaker 1 (260602 Touchpoint)
If we start at the top,
9:45
S… Speaker 1 (260602 Touchpoint)
let's assume hypothetically RSV arrives this week,
9:49
S… Speaker 1 (260602 Touchpoint)
you wait for that deficiency round to arrive to see what else we need to
9:53
S… Speaker 1 (260602 Touchpoint)
edit and amend as per the deficiency round and then in the
9:57
S… Speaker 1 (260602 Touchpoint)
same boat,
9:58
S… Speaker 1 (260602 Touchpoint)
you make that update.
10:00
S… Speaker 3 (260602 Touchpoint)
for RSV and then same idea you wait for Shagas which
10:04
S… Speaker 3 (260602 Touchpoint)
will probably be in July or August let's hope July then
10:08
S… Speaker 3 (260602 Touchpoint)
you do the same thing and for Rotadino you would be waiting
10:13
S… Speaker 3 (260602 Touchpoint)
for deficiency round one round about November to
10:17
S… Speaker 1 (260602 Touchpoint)
do that no so you what
10:22
S… Speaker 1 (260602 Touchpoint)
you said for RSV and Shagas is correct but for
10:27
S… Speaker 1 (260602 Touchpoint)
Rotadino there
10:29
S… Speaker 1 (260602 Touchpoint)
they said different thing because we did not
10:33
S… Speaker 1 (260602 Touchpoint)
have submitted yet.
10:35
S… Speaker 1 (260602 Touchpoint)
So they said we have still
10:39
S… Speaker 1 (260602 Touchpoint)
time to change
10:46
S… Speaker 1 (260602 Touchpoint)
our raw material name and then we
10:50
S… Speaker 1 (260602 Touchpoint)
can update our IFU and let's submit July
10:55
S… Speaker 1 (260602 Touchpoint)
with updated version of
10:58
S… Speaker 1 (260602 Touchpoint)
raw materials name.
10:59
S… Speaker 1 (260602 Touchpoint)
So that I think that's really,
11:03
S… Speaker 1 (260602 Touchpoint)
really,
11:03
S… Speaker 1 (260602 Touchpoint)
really, that will be really,
11:04
S… Speaker 1 (260602 Touchpoint)
really tough because we need to open
11:09
S… Speaker 1 (260602 Touchpoint)
a change because originally we had
11:13
S… Speaker 1 (260602 Touchpoint)
a change for raw materials
11:17
S… Speaker 1 (260602 Touchpoint)
names,
11:18
S… Speaker 1 (260602 Touchpoint)
but Rotadino.
11:21
S… Speaker 1 (260602 Touchpoint)
has out of scope from this change request
11:27
S… Speaker 1 (260602 Touchpoint)
because there was some issue regarding
11:31
S… Speaker 1 (260602 Touchpoint)
the T line,
11:33
S… Speaker 1 (260602 Touchpoint)
which is now we don't have any worry
11:37
S… Speaker 1 (260602 Touchpoint)
about that.
11:37
S… Speaker 1 (260602 Touchpoint)
So it is now right now released.
11:42
S… Speaker 1 (260602 Touchpoint)
it the cr has already been released so we cannot add
11:47
S… Speaker 1 (260602 Touchpoint)
the rotaidino to into this cr that means we need to
11:51
S… Speaker 1 (260602 Touchpoint)
open a new one so we need to open a
11:55
S… Speaker 1 (260602 Touchpoint)
new one new cr for updating dmr
12:00
S… Speaker 1 (260602 Touchpoint)
so that this is the
12:04
S… Speaker 1 (260602 Touchpoint)
schedule for DCRB meeting.
12:07
S… Speaker 1 (260602 Touchpoint)
So we have already almost full for July
12:13
S… Speaker 1 (260602 Touchpoint)
2nd and 4th.
12:14
S… Speaker 1 (260602 Touchpoint)
So we have to do our DCRB meeting at July 9th.
12:20
S… Speaker 1 (260602 Touchpoint)
So that's our DCRB meeting and CROpen collaboration
12:24
S… Speaker 1 (260602 Touchpoint)
and review proposal and release.
12:26
S… Speaker 1 (260602 Touchpoint)
And after that,
12:27
S… Speaker 1 (260602 Touchpoint)
we can have an action to update MDF,
12:30
S… Speaker 1 (260602 Touchpoint)
which is DMR.
12:31
S… Speaker 1 (260602 Touchpoint)
And we have approval.
12:33
S… Speaker 1 (260602 Touchpoint)
And after that,
12:34
S… Speaker 1 (260602 Touchpoint)
we can move on to the IFU.
12:37
S… Speaker 1 (260602 Touchpoint)
And that makes our June.
12:43
S… Speaker 1 (260602 Touchpoint)
After that,
12:44
S… Speaker 1 (260602 Touchpoint)
we have to make all of our critical
12:48
S… Speaker 1 (260602 Touchpoint)
approval documents within only a month.
12:52
S… Speaker 1 (260602 Touchpoint)
So I think that's not realistic and that cannot be happened.
12:56
S… Speaker 1 (260602 Touchpoint)
So I think we have to reflect this change after
13:01
S… Speaker 1 (260602 Touchpoint)
the initial submission.
13:02
S… Speaker 1 (260602 Touchpoint)
So fortunately,
13:04
S… Speaker 1 (260602 Touchpoint)
Boram is right now here.
13:06
S… Speaker 1 (260602 Touchpoint)
So what do you think about that?
13:08
S… Speaker 1 (260602 Touchpoint)
Does that make sense?
13:19
S… Speaker 1 (260602 Touchpoint)
Yes,
13:20
S… Speaker 1 (260602 Touchpoint)
can I explain again,
13:22
S… Speaker 1 (260602 Touchpoint)
maybe?
13:22
S… Speaker 2 (260602 Touchpoint)
Yes,
13:31
S… Speaker 1 (260602 Touchpoint)
just for a moment,
13:33
S… Speaker 1 (260602 Touchpoint)
I will use Korean,
13:34
S… Speaker 1 (260602 Touchpoint)
sorry for that.
13:41
S… Speaker 2 (260602 Touchpoint)
I'm going to take a look at it.
13:44
S… Speaker 2 (260602 Touchpoint)
I'm going to take a look at it.
13:46
S… Speaker 2 (260602 Touchpoint)
I'm going to take a look at it.
13:50
S… Speaker 2 (260602 Touchpoint)
I'm going to take a look at it.
13:52
S… Speaker 2 (260602 Touchpoint)
I'm going to take a look at
14:00
S… Speaker 2 (260602 Touchpoint)
it.
14:11
S… Speaker 1 (260602 Touchpoint)
. . . . .
14:34
S… Speaker 2 (260602 Touchpoint)
. . . .
15:00
S… Speaker 1 (260602 Touchpoint)
I don't think it's possible.
15:02
S… Speaker 1 (260602 Touchpoint)
And I think PMO is going to talk about 7月31日.
15:05
S… Speaker 1 (260602 Touchpoint)
I think it's not possible to do this.
15:07
S… Speaker 1 (260602 Touchpoint)
I think it's possible to do this,
15:10
S… Speaker 1 (260602 Touchpoint)
but I think it's hard to do it.
15:14
S… Speaker 3 (260602 Touchpoint)
But it's time for me to really take a long time.
15:17
S… Speaker 3 (260602 Touchpoint)
It was a week ago.
15:20
S… Speaker 3 (260602 Touchpoint)
We had a collaboration with a couple of weeks ago.
15:23
S… Speaker 3 (260602 Touchpoint)
But we had a lot of the changes
15:27
S… Speaker 3 (260602 Touchpoint)
in the same way.
15:28
S… Speaker 3 (260602 Touchpoint)
We had a lot of changes in the same way.
15:30
S… Speaker 3 (260602 Touchpoint)
We had a lot of changes in the same way.
15:31
S… Speaker 3 (260602 Touchpoint)
We had a lot of changes in the same way.
15:34
S… Speaker 3 (260602 Touchpoint)
We had a lot of changes in the same way.
15:36
S… Speaker 3 (260602 Touchpoint)
Yes,
15:37
S… Speaker 1 (260602 Touchpoint)
I do.
15:38
S… Speaker 3 (260602 Touchpoint)
But I don't think it's going to be more difficult to do that.
15:42
S… Speaker 3 (260602 Touchpoint)
And the MDF update is also going to
15:47
S… Speaker 3 (260602 Touchpoint)
be a long time.
15:48
S… Speaker 3 (260602 Touchpoint)
The POs' articles,
15:50
S… Speaker 3 (260602 Touchpoint)
we can see RMP,
15:52
S… Speaker 3 (260602 Touchpoint)
PSUC,
15:53
S… Speaker 3 (260602 Touchpoint)
HAR 3g,
15:54
S… Speaker 3 (260602 Touchpoint)
SOTA,
15:57
S… Speaker 3 (260602 Touchpoint)
SOTA, SOTA 3g,
15:58
S… Speaker 3 (260602 Touchpoint)
SOTA, SOTA 3g,
15:59
S… Speaker 3 (260602 Touchpoint)
SOTA 3g.
16:03
S… Speaker 1 (260602 Touchpoint)
First of all,
16:04
S… Speaker 1 (260602 Touchpoint)
MDF is when I asked the QADC
16:08
S… Speaker 1 (260602 Touchpoint)
team about MDF update,
16:11
S… Speaker 1 (260602 Touchpoint)
it has been a long time for 5 days.
16:13
S… Speaker 1 (260602 Touchpoint)
If
16:19
S… Speaker 3 (260602 Touchpoint)
I had a question about the DA,
16:20
S… Speaker 3 (260602 Touchpoint)
I would say that if we
16:24
S… Speaker 3 (260602 Touchpoint)
are not able to do it now,
16:25
S… Speaker 3 (260602 Touchpoint)
we are going to go.
16:27
S… Speaker 3 (260602 Touchpoint)
I think it's important to update all of the things that we need to update all of the things that we need to update all of the
16:33
S… Speaker 3 (260602 Touchpoint)
things that we need to update all of the things that we
16:37
S… Speaker 3 (260602 Touchpoint)
need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things
16:41
S… Speaker 3 (260602 Touchpoint)
that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things that we need to update all of the things
16:45
S… Speaker 3 (260602 Touchpoint)
that we need to update all of the things that
16:50
S… Speaker 3 (260602 Touchpoint)
we need to update all
17:17
S… Speaker 1 (260602 Touchpoint)
So yes,
17:18
S… Speaker 1 (260602 Touchpoint)
let's return into English.
17:20
S… Speaker 1 (260602 Touchpoint)
So we have discussed about that.
17:31
S… Speaker 1 (260602 Touchpoint)
This schedule takes so long,
17:34
S… Speaker 1 (260602 Touchpoint)
so we have to shorten these days so
17:39
S… Speaker 1 (260602 Touchpoint)
that they have more time to make
17:44
S… Speaker 1 (260602 Touchpoint)
some review and approval.
17:49
S… Speaker 2 (260602 Touchpoint)
I think I realize this is a shorter version of our regular
17:53
S… Speaker 1 (260602 Touchpoint)
tracker.
17:53
S… Speaker 2 (260602 Touchpoint)
Could you just bring up our regular tracker quickly just so that I can show what
17:58
S… Speaker 2 (260602 Touchpoint)
the consequential impact is going to be here?
18:01
S… Speaker 2 (260602 Touchpoint)
So you see over here,
18:03
S… Speaker 2 (260602 Touchpoint)
the yellow line is where we are today.
18:06
S… Speaker 3 (260602 Touchpoint)
Yes.
18:07
S… Speaker 2 (260602 Touchpoint)
If you look at the
18:11
S… Speaker 2 (260602 Touchpoint)
left of that,
18:12
S… Speaker 2 (260602 Touchpoint)
where we were initially...
18:15
S… Speaker 2 (260602 Touchpoint)
required to get the IFU approval going.
18:18
S… Speaker 2 (260602 Touchpoint)
And we all know that it starts with the design parts
18:22
S… Speaker 2 (260602 Touchpoint)
and then the IFU approval and then the dominoes fall from there.
18:25
S… Speaker 2 (260602 Touchpoint)
This is already a very,
18:28
S… Speaker 2 (260602 Touchpoint)
very compressed timeline to meet a second deadline
18:33
S… Speaker 2 (260602 Touchpoint)
of 31.
18:34
S… Speaker 2 (260602 Touchpoint)
July,
18:35
S… Speaker 2 (260602 Touchpoint)
for which we will not have permission to move out again because
18:39
S… Speaker 2 (260602 Touchpoint)
this program has goals that is elevated to executive
18:43
S… Speaker 1 (260602 Touchpoint)
level.
18:44
S… Speaker 2 (260602 Touchpoint)
We have to have this submitted by the 31st of July.
18:47
S… Speaker 2 (260602 Touchpoint)
If the concern here is if that change
18:51
S… Speaker 2 (260602 Touchpoint)
request is raised and there's a new version that
18:55
S… Speaker 2 (260602 Touchpoint)
we do not want to submit without updating to
19:00
S… Speaker 2 (260602 Touchpoint)
the new version of that particular one label.
19:03
S… Speaker 2 (260602 Touchpoint)
then my suggestion would be to hold back the
19:07
S… Speaker 2 (260602 Touchpoint)
CRB review and approval of that change
19:12
S… Speaker 2 (260602 Touchpoint)
request until after submission.
19:13
S… Speaker 2 (260602 Touchpoint)
The reason for this is,
19:15
S… Speaker 2 (260602 Touchpoint)
folks, we have to handle this like a design freeze.
19:18
S… Speaker 2 (260602 Touchpoint)
If we are going to say every time,
19:20
S… Speaker 2 (260602 Touchpoint)
oh, we'll just wait for one more change,
19:22
S… Speaker 2 (260602 Touchpoint)
we'll just wait for one more change,
19:24
S… Speaker 2 (260602 Touchpoint)
there is a six to eight week approval sequence.
19:28
S… Speaker 2 (260602 Touchpoint)
that we delay every time we do this.
19:30
S… Speaker 2 (260602 Touchpoint)
We are already late with the IFU.
19:33
S… Speaker 2 (260602 Touchpoint)
We have now gone to an approval plan
19:37
S… Speaker 2 (260602 Touchpoint)
version 9 with all of these adjustments and we cannot do that again.
19:41
S… Speaker 2 (260602 Touchpoint)
I do not see any justified reason to do this.
19:44
S… Speaker 2 (260602 Touchpoint)
This is not affecting the safety of the performance of the device.
19:47
S… Speaker 2 (260602 Touchpoint)
Yes,
19:48
S… Speaker 2 (260602 Touchpoint)
we've identified there's a name change that needs to happen,
19:50
S… Speaker 2 (260602 Touchpoint)
but the appropriate time for that would be after we've submitted
19:55
S… Speaker 2 (260602 Touchpoint)
it because this file stays technically in a draft version
19:59
S… Speaker 2 (260602 Touchpoint)
until
20:00
S… Speaker 3 (260602 Touchpoint)
that day that the full IVDR certificate is released.
20:04
S… Speaker 3 (260602 Touchpoint)
So we have time until then,
20:06
S… Speaker 3 (260602 Touchpoint)
and the best way to deal with this would be after submission.
20:10
S… Speaker 3 (260602 Touchpoint)
If we make a delay now,
20:11
S… Speaker 3 (260602 Touchpoint)
I do not see how we will recover to
20:16
S… Speaker 3 (260602 Touchpoint)
meet 31 July,
20:17
S… Speaker 3 (260602 Touchpoint)
if we are already behind our IVU approval.
20:32
S… Speaker 2 (260602 Touchpoint)
update at this time and submit at once,
20:37
S… Speaker 2 (260602 Touchpoint)
because if we delay the CR,
20:40
S… Speaker 2 (260602 Touchpoint)
then we have to update documents twice or
20:45
S… Speaker 2 (260602 Touchpoint)
each document needs to be revised twice.
20:47
S… Speaker 2 (260602 Touchpoint)
It's burden and also in
20:52
S… Speaker 2 (260602 Touchpoint)
IVDR implementation project,
20:55
S… Speaker 2 (260602 Touchpoint)
we already decided.
20:59
S… Speaker 2 (260602 Touchpoint)
Even if we didn't meet the timeline,
21:02
S… Speaker 2 (260602 Touchpoint)
we had to update all things at once.
21:05
S… Speaker 2 (260602 Touchpoint)
In case of raw material
21:10
S… Speaker 2 (260602 Touchpoint)
name also,
21:11
S… Speaker 2 (260602 Touchpoint)
we decided to reflect all things and
21:15
S… Speaker 2 (260602 Touchpoint)
then suddenly it was decided in the implementation page because
21:19
S… Speaker 2 (260602 Touchpoint)
of RA's opinion,
21:21
S… Speaker 2 (260602 Touchpoint)
regulatory.
21:23
S… Speaker 2 (260602 Touchpoint)
because of regulatory impact,
21:26
S… Speaker 2 (260602 Touchpoint)
because we have to submit twice.
21:28
S… Speaker 2 (260602 Touchpoint)
And in my thought,
21:31
S… Speaker 2 (260602 Touchpoint)
we already had impact assessment for
21:36
S… Speaker 2 (260602 Touchpoint)
IVDR product regarding same issue,
21:39
S… Speaker 2 (260602 Touchpoint)
same case.
21:40
S… Speaker 2 (260602 Touchpoint)
And also in case of NDF,
21:44
S… Speaker 2 (260602 Touchpoint)
we can prepare drafting before CR release.
21:50
S… Speaker 2 (260602 Touchpoint)
prepare earlier,
21:52
S… Speaker 2 (260602 Touchpoint)
then just approve the NDF files
21:56
S… Speaker 2 (260602 Touchpoint)
and IFU just after
22:00
S… Speaker 2 (260602 Touchpoint)
CR approval.
22:02
S… Speaker 2 (260602 Touchpoint)
In my view,
22:04
S… Speaker 2 (260602 Touchpoint)
I don't think it takes too much time as
22:08
S… Speaker 2 (260602 Touchpoint)
Gain showed.
22:09
S… Speaker 2 (260602 Touchpoint)
Please consider how
22:17
S… Speaker 2 (260602 Touchpoint)
we can shorten the timeline.
22:20
S… Speaker 2 (260602 Touchpoint)
If we can,
22:21
S… Speaker 2 (260602 Touchpoint)
I think we have to reflect it at
22:25
S… Speaker 2 (260602 Touchpoint)
this time.
22:26
S… Speaker 2 (260602 Touchpoint)
So please reconsider the timeline.
22:29
S… Speaker 2 (260602 Touchpoint)
I think Kain's timeline is too long.
22:33
S… Speaker 3 (260602 Touchpoint)
Can you explain to
22:37
S… Speaker 3 (260602 Touchpoint)
me? You say there will be double the updates.
22:40
S… Speaker 3 (260602 Touchpoint)
Can you explain to me precisely which documents are updated so that
22:44
S… Speaker 3 (260602 Touchpoint)
I can understand it better in the context of this?
22:47
S… Speaker 2 (260602 Touchpoint)
I don't
22:58
S… Speaker 2 (260602 Touchpoint)
know about the other documents but if we change the raw
23:02
S… Speaker 2 (260602 Touchpoint)
material name then maybe some documents can affect it and
23:06
S… Speaker 2 (260602 Touchpoint)
we have to revise it once again.
23:09
S… Speaker 1 (260602 Touchpoint)
So, yes,
23:10
S… Speaker 1 (260602 Touchpoint)
I have a list of,
23:13
S… Speaker 1 (260602 Touchpoint)
I'm sorry, it is in Korean.
23:15
S… Speaker 1 (260602 Touchpoint)
So I have a list that is impacted from the raw materials.
23:19
S… Speaker 1 (260602 Touchpoint)
So that's DMR,
23:21
S… Speaker 1 (260602 Touchpoint)
which is MDF,
23:23
S… Speaker 1 (260602 Touchpoint)
and IFU,
23:24
S… Speaker 1 (260602 Touchpoint)
EDO,
23:24
S… Speaker 1 (260602 Touchpoint)
and the regulation thing,
23:27
S… Speaker 1 (260602 Touchpoint)
dominant regulation thing,
23:29
S… Speaker 1 (260602 Touchpoint)
MFDS,
23:30
S… Speaker 1 (260602 Touchpoint)
and BMR,
23:32
S… Speaker 1 (260602 Touchpoint)
and also stat for chapter one and chapter three.
23:35
S… Speaker 1 (260602 Touchpoint)
So that's all,
23:37
S… Speaker 1 (260602 Touchpoint)
I think.
23:39
S… Speaker 3 (260602 Touchpoint)
So the only way I could consider this is
23:43
S… Speaker 3 (260602 Touchpoint)
if you could sit with a CFD and look at this detailed
23:48
S… Speaker 3 (260602 Touchpoint)
daily plan and show me how we are still going to reach submission
23:52
S… Speaker 3 (260602 Touchpoint)
file ready before end
23:56
S… Speaker 1 (260602 Touchpoint)
of July.
23:57
S… Speaker 3 (260602 Touchpoint)
My concern is you'll see the purple here you've got.
24:01
S… Speaker 3 (260602 Touchpoint)
I think that's another audit coming up as well,
24:03
S… Speaker 1 (260602 Touchpoint)
isn't it?
24:03
S… Speaker 3 (260602 Touchpoint)
So that's another week where it's going to be difficult.
24:08
S… Speaker 3 (260602 Touchpoint)
to get items done and released.
24:11
S… Speaker 3 (260602 Touchpoint)
So show me how with the delay of the approval,
24:16
S… Speaker 3 (260602 Touchpoint)
what is TechOps opinion here on the big piece
24:20
S… Speaker 1 (260602 Touchpoint)
of work?
24:20
S… Speaker 3 (260602 Touchpoint)
You've got chapter five and chapter six that sits and waits for EDO,
24:25
S… Speaker 3 (260602 Touchpoint)
DTM and IFU to be released before they can even touch those deliverables.
24:29
S… Speaker 4 (260602 Touchpoint)
Yes,
24:33
S… Speaker 1 (260602 Touchpoint)
in fact,
24:34
S… Speaker 1 (260602 Touchpoint)
so I am on the same.
24:36
S… Speaker 1 (260602 Touchpoint)
uh same opinion so it seems we
24:41
S… Speaker 1 (260602 Touchpoint)
cannot meet the submission timeline
24:45
S… Speaker 1 (260602 Touchpoint)
even if we add the dmr
24:50
S… Speaker 1 (260602 Touchpoint)
update into these maybe five or six days it
24:54
S… Speaker 1 (260602 Touchpoint)
will be uh yes also and also
24:58
S… Speaker 1 (260602 Touchpoint)
i ask
25:00
S… Speaker 3 (260602 Touchpoint)
Yubin who is responsible for IFU and Yubin said she
25:05
S… Speaker 3 (260602 Touchpoint)
needs at least three days to make
25:10
S… Speaker 3 (260602 Touchpoint)
it implemented after the DMR
25:14
S… Speaker 3 (260602 Touchpoint)
is ready.
25:15
S… Speaker 3 (260602 Touchpoint)
So if there is some five days and
25:19
S… Speaker 3 (260602 Touchpoint)
three days and we have no time.
25:22
S… Speaker 6 (260602 Touchpoint)
Do you want to add something?
25:25
S… Speaker 2 (260602 Touchpoint)
But why we can't prepare them in parallel?
25:30
S… Speaker 5 (260602 Touchpoint)
To be honest,
25:31
S… Speaker 5 (260602 Touchpoint)
I agree with DA's suggestion.
25:34
S… Speaker 5 (260602 Touchpoint)
Given that this can be handled in advance,
25:36
S… Speaker 5 (260602 Touchpoint)
we could apply it into the technical documentation draft before
25:40
S… Speaker 5 (260602 Touchpoint)
the CR release.
25:41
S… Speaker 5 (260602 Touchpoint)
We accumulated the change part of raw material,
25:44
S… Speaker 5 (260602 Touchpoint)
which would likely minimize the world
25:48
S… Speaker 5 (260602 Touchpoint)
timeline impact.
25:49
S… Speaker 5 (260602 Touchpoint)
Could we consider including it in this round?
25:53
S… Speaker 5 (260602 Touchpoint)
I think we can apply this change in advance,
25:57
S… Speaker 5 (260602 Touchpoint)
so it cannot make
26:03
S… Speaker 1 (260602 Touchpoint)
My concern is,
26:04
S… Speaker 1 (260602 Touchpoint)
you see where the yellow is now.
26:07
S… Speaker 1 (260602 Touchpoint)
We're supposed to be in the collaboration stage with the IFU at the moment.
26:11
S… Speaker 1 (260602 Touchpoint)
We're not,
26:12
S… Speaker 6 (260602 Touchpoint)
are we?
26:13
S… Speaker 1 (260602 Touchpoint)
The moment we say,
26:16
S… Speaker 7 (260602 Touchpoint)
wait,
26:17
S… Speaker 1 (260602 Touchpoint)
we are now going to go back,
26:18
S… Speaker 1 (260602 Touchpoint)
update the EDO again,
26:20
S… Speaker 1 (260602 Touchpoint)
update the DTM again,
26:21
S… Speaker 1 (260602 Touchpoint)
how many weeks we're going to be tracking behind before we actually start
26:25
S… Speaker 1 (260602 Touchpoint)
with the approval chain?
26:28
S… Speaker 1 (260602 Touchpoint)
of the IFU,
26:29
S… Speaker 1 (260602 Touchpoint)
which is the gating factor for the bulk of the approvals
26:33
S… Speaker 1 (260602 Touchpoint)
for chapter five and six and then zero to four after that.
26:39
S… Speaker 3 (260602 Touchpoint)
I understand both Mandy's opinion and Boram's
26:43
S… Speaker 1 (260602 Touchpoint)
opinion.
26:44
S… Speaker 3 (260602 Touchpoint)
So I understand both of them.
26:46
S… Speaker 3 (260602 Touchpoint)
So I think anyway,
26:49
S… Speaker 3 (260602 Touchpoint)
if we try to put this change into our
26:53
S… Speaker 3 (260602 Touchpoint)
initial submission,
26:54
S… Speaker 3 (260602 Touchpoint)
we have to squeeze TO
26:59
S… Speaker 3 (260602 Touchpoint)
and RA.
27:00
S… Speaker 3 (260602 Touchpoint)
So we have no choice to squeeze them.
27:03
S… Speaker 3 (260602 Touchpoint)
So I think we have to discuss
27:08
S… Speaker 1 (260602 Touchpoint)
with
27:08
S… Speaker 2 (260602 Touchpoint)
Discuss with Tio and Aria.
27:10
S… Speaker 1 (260602 Touchpoint)
If you can get alignment for both of them that this could be achievable,
27:14
S… Speaker 1 (260602 Touchpoint)
then I'm okay to do that.
27:15
S… Speaker 1 (260602 Touchpoint)
If there's too much risk,
27:18
S… Speaker 1 (260602 Touchpoint)
I need you to take in consideration you're not going to do this twice.
27:22
S… Speaker 1 (260602 Touchpoint)
You're going to make that change once.
27:24
S… Speaker 1 (260602 Touchpoint)
It's just a question of do we make it before July or do we
27:28
S… Speaker 1 (260602 Touchpoint)
make it after July?
27:30
S… Speaker 2 (260602 Touchpoint)
Yes,
27:30
S… Speaker 3 (260602 Touchpoint)
I will talk into the CFT's cross -functional
27:34
S… Speaker 3 (260602 Touchpoint)
teams in Thursday.
27:37
S… Speaker 3 (260602 Touchpoint)
We have working session on Thursday and I hope hopefully
27:42
S… Speaker 3 (260602 Touchpoint)
I can share the conclusion with you in your morning.
27:46
S… Speaker 6 (260602 Touchpoint)
Thank you.
27:50
S… Speaker 2 (260602 Touchpoint)
Yes.
27:51
S… Speaker 1 (260602 Touchpoint)
So yes,
27:53
S… Speaker 3 (260602 Touchpoint)
that was so long for that was so long.
27:56
S… Speaker 7 (260602 Touchpoint)
Yeah.
27:59
S… Speaker 3 (260602 Touchpoint)
come back to our touchpoints agenda.
28:02
S… Speaker 3 (260602 Touchpoint)
So we have talked about that,
28:05
S… Speaker 3 (260602 Touchpoint)
talked about that.
28:06
S… Speaker 3 (260602 Touchpoint)
And we also have talked about that.
28:10
S… Speaker 3 (260602 Touchpoint)
Yes,
28:11
S… Speaker 3 (260602 Touchpoint)
we are all okay with that bio kit was
28:15
S… Speaker 3 (260602 Touchpoint)
not a rich violation,
28:17
S… Speaker 3 (260602 Touchpoint)
but with the Montereo protocol,

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