2026-06-30 weekly meeting
Jun 30, 2026 08:44
· 19:05
· English
· Whisper Turbo
· 4 Locutores
Haec pagina de translatio explicat.
Despectus in Viam Permanentem →
Videtur solum
0:00
S…
Speaker 2 (2026-06-30 weekly meeting)
Good morning,
0:01
S…
Speaker 2 (2026-06-30 weekly meeting)
Mandy.
0:02
S…
Speaker 1 (2026-06-30 weekly meeting)
Hi,
0:04
S…
Speaker 1 (2026-06-30 weekly meeting)
Alex.
0:04
S…
Speaker 1 (2026-06-30 weekly meeting)
Good morning,
0:06
S…
Speaker 1 (2026-06-30 weekly meeting)
everyone.
0:06
S…
Speaker 1 (2026-06-30 weekly meeting)
Good morning.
0:09
S…
Speaker 1 (2026-06-30 weekly meeting)
Are
0:13
S…
Speaker 1 (2026-06-30 weekly meeting)
they all
0:47
S…
Speaker 2 (2026-06-30 weekly meeting)
for this meeting?
0:48
S…
Speaker 1 (2026-06-30 weekly meeting)
Maybe
0:52
S…
Speaker 1 (2026-06-30 weekly meeting)
it's just us.
0:53
S…
Speaker 1 (2026-06-30 weekly meeting)
Could
0:58
S…
Speaker 2 (2026-06-30 weekly meeting)
you wait for...
0:59
S…
Speaker 1 (2026-06-30 weekly meeting)
We can give it a minute.
1:02
S…
Speaker 2 (2026-06-30 weekly meeting)
Okay, sure.
1:03
S…
Speaker 1 (2026-06-30 weekly meeting)
Alright,
2:06
S…
Speaker 1 (2026-06-30 weekly meeting)
I think we probably have enough to get going.
2:07
S…
Speaker 1 (2026-06-30 weekly meeting)
If we can proceed,
2:08
S…
Speaker 1 (2026-06-30 weekly meeting)
please.
2:09
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay.
2:12
S…
Speaker 2 (2026-06-30 weekly meeting)
um today's sudden there's four rsb just
2:16
S…
Speaker 2 (2026-06-30 weekly meeting)
status for some documents for tier two
2:21
S…
Speaker 2 (2026-06-30 weekly meeting)
so if an avaling is in final forward just
2:25
S…
Speaker 2 (2026-06-30 weekly meeting)
one person is left for approval so
2:29
S…
Speaker 2 (2026-06-30 weekly meeting)
i just expected to implement it by today and
2:34
S…
Speaker 2 (2026-06-30 weekly meeting)
then tps document is in collaboration maybe this
2:39
S…
Speaker 2 (2026-06-30 weekly meeting)
one will be
2:42
S…
Speaker 2 (2026-06-30 weekly meeting)
The timeline here,
2:45
S…
Speaker 2 (2026-06-30 weekly meeting)
so maybe July
2:49
S…
Speaker 2 (2026-06-30 weekly meeting)
7th will be implemented in July
2:54
S…
Speaker 2 (2026-06-30 weekly meeting)
7th.
2:54
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay.
2:56
S…
Speaker 2 (2026-06-30 weekly meeting)
And then RA document is drafting now by Jisoo and
3:00
S…
Speaker 2 (2026-06-30 weekly meeting)
direct response draft by Clover,
3:02
S…
Speaker 2 (2026-06-30 weekly meeting)
I heard from Mendy.
3:04
S…
Speaker 2 (2026-06-30 weekly meeting)
And then we can review for that.
3:07
S…
Speaker 2 (2026-06-30 weekly meeting)
So is there any timeline for?
3:10
S…
Speaker 2 (2026-06-30 weekly meeting)
Any drafts for DR2?
3:11
S…
Speaker 1 (2026-06-30 weekly meeting)
Yes, I am busy with making some refinements.
3:15
S…
Speaker 1 (2026-06-30 weekly meeting)
And then I should let you know by the end of today,
3:18
S…
Speaker 1 (2026-06-30 weekly meeting)
I'd like you to then start looking at it.
3:21
S…
Speaker 1 (2026-06-30 weekly meeting)
Unum,
3:22
S…
Speaker 1 (2026-06-30 weekly meeting)
I think I've sent it to you.
3:23
S…
Speaker 1 (2026-06-30 weekly meeting)
Or who else would like to review that?
3:25
S…
Speaker 1 (2026-06-30 weekly meeting)
I think it's basically just to see if you agree with
3:30
S…
Speaker 1 (2026-06-30 weekly meeting)
the responses we've drafted and to just put the appropriate appendix or
3:34
S…
Speaker 1 (2026-06-30 weekly meeting)
attachment reference of what we're updating against there.
3:38
S…
Speaker 1 (2026-06-30 weekly meeting)
So we've put...
3:38
S…
Speaker 1 (2026-06-30 weekly meeting)
placeholders in there for that and then once we're happy with that I have Katrina
3:43
S…
Speaker 1 (2026-06-30 weekly meeting)
on standby to then do the final review and give us a
3:47
S…
Speaker 1 (2026-06-30 weekly meeting)
go ahead with the wording that we've added to the response is acceptable to
3:52
S…
Speaker 1 (2026-06-30 weekly meeting)
then send away I think the 10th we are still aiming for right July along
3:56
S…
Speaker 1 (2026-06-30 weekly meeting)
with the response and the updated documents so the
4:03
S…
Speaker 2 (2026-06-30 weekly meeting)
manager for RSV in RA department is Jisoo
4:07
S…
Speaker 2 (2026-06-30 weekly meeting)
but okay
4:09
S…
Speaker 2 (2026-06-30 weekly meeting)
Yeah, please send to her and report
4:13
S…
Speaker 2 (2026-06-30 weekly meeting)
to Yurim as well.
4:15
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay,
4:16
S…
Speaker 1 (2026-06-30 weekly meeting)
I'll copy Yurim.
4:18
S…
Speaker 2 (2026-06-30 weekly meeting)
And then how many days do you need for senior review?
4:23
S…
Speaker 2 (2026-06-30 weekly meeting)
i expect five days but we have we need to it'll
4:27
S…
Speaker 1 (2026-06-30 weekly meeting)
be less it'll be less than that so if we can get um
4:32
S…
Speaker 1 (2026-06-30 weekly meeting)
if you can i mean it's only a couple of responses right so jisoo should
4:36
S…
Speaker 1 (2026-06-30 weekly meeting)
be able to just have a look at that maybe by friday and then on monday i
4:41
S…
Speaker 1 (2026-06-30 weekly meeting)
can uh wait why am i saying by friday what's today sorry it's
4:45
S…
Speaker 1 (2026-06-30 weekly meeting)
tuesday
4:48
S…
Speaker 1 (2026-06-30 weekly meeting)
By Wednesday,
4:49
S…
Speaker 1 (2026-06-30 weekly meeting)
I can ask Katrina to look at it and give
4:53
S…
Speaker 1 (2026-06-30 weekly meeting)
us the OK by Friday.
4:54
S…
Speaker 1 (2026-06-30 weekly meeting)
We should be then ready to
4:58
S…
Speaker 1 (2026-06-30 weekly meeting)
get all the final pieces.
5:00
S…
Speaker 4 (2026-06-30 weekly meeting)
together in that last week but um i
5:04
S…
Speaker 3 (2026-06-30 weekly meeting)
think we need to have a maybe today is
5:08
S…
Speaker 3 (2026-06-30 weekly meeting)
almost done so i think we can review why uh
5:12
S…
Speaker 3 (2026-06-30 weekly meeting)
until thursday or friday in adk
5:18
S…
Speaker 4 (2026-06-30 weekly meeting)
If we drive for Thursday,
5:21
S…
Speaker 4 (2026-06-30 weekly meeting)
then on Thursday afternoon,
5:22
S…
Speaker 4 (2026-06-30 weekly meeting)
which is the end of your day,
5:24
S…
Speaker 4 (2026-06-30 weekly meeting)
then I can let Katrina know.
5:27
S…
Speaker 4 (2026-06-30 weekly meeting)
Then she gets the rest of Thursday and Friday to look at it.
5:30
S…
Speaker 4 (2026-06-30 weekly meeting)
So that Monday,
5:31
S…
Speaker 4 (2026-06-30 weekly meeting)
we are ready with everything we need.
5:33
S…
Speaker 2 (2026-06-30 weekly meeting)
Okay,
5:34
S…
Speaker 3 (2026-06-30 weekly meeting)
I will try.
5:35
S…
Speaker 3 (2026-06-30 weekly meeting)
But if there is any updates,
5:37
S…
Speaker 3 (2026-06-30 weekly meeting)
maybe I can let you know.
5:40
S…
Speaker 4 (2026-06-30 weekly meeting)
Okay, sure.
5:41
S…
Speaker 2 (2026-06-30 weekly meeting)
And then this
5:45
S…
Speaker 3 (2026-06-30 weekly meeting)
all for RSPs,
5:47
S…
Speaker 3 (2026-06-30 weekly meeting)
is there any comments for that?
5:50
S…
Speaker 4 (2026-06-30 weekly meeting)
No, we look like we're all on track for the test.
5:53
S…
Speaker 4 (2026-06-30 weekly meeting)
So I'm happy with that.
5:55
S…
Speaker 2 (2026-06-30 weekly meeting)
Thank you.
5:56
S…
Speaker 3 (2026-06-30 weekly meeting)
And this is Shaga's product.
5:59
S…
Speaker 3 (2026-06-30 weekly meeting)
So SSP is ours request
6:04
S…
Speaker 3 (2026-06-30 weekly meeting)
from TUV.
6:06
S…
Speaker 3 (2026-06-30 weekly meeting)
So TPS team updated the documents.
6:10
S…
Speaker 3 (2026-06-30 weekly meeting)
And you can check the status
6:14
S…
Speaker 3 (2026-06-30 weekly meeting)
in this CO.
6:15
S…
Speaker 3 (2026-06-30 weekly meeting)
These are in collaboration.
6:18
S…
Speaker 3 (2026-06-30 weekly meeting)
And then I can update you if there is any change
6:24
S…
Speaker 1 (2026-06-30 weekly meeting)
of status.
6:25
S…
Speaker 4 (2026-06-30 weekly meeting)
I think we were aiming for the end of this week.
6:28
S…
Speaker 4 (2026-06-30 weekly meeting)
Is that correct?
6:29
S…
Speaker 1 (2026-06-30 weekly meeting)
I heard it from
6:33
S…
Speaker 1 (2026-06-30 weekly meeting)
TO team.
6:34
S…
Speaker 1 (2026-06-30 weekly meeting)
They can finalize it until 2nd of
6:38
S…
Speaker 1 (2026-06-30 weekly meeting)
July.
6:38
S…
Speaker 1 (2026-06-30 weekly meeting)
So I think I can share it with you no
6:43
S…
Speaker 1 (2026-06-30 weekly meeting)
later than this week.
6:45
S…
Speaker 4 (2026-06-30 weekly meeting)
Okay, so once it's done,
6:47
S…
Speaker 4 (2026-06-30 weekly meeting)
all we need to do is just upload it back onto the UCI.
6:51
S…
Speaker 4 (2026-06-30 weekly meeting)
But that can either be me or Yulin.
6:53
S…
Speaker 4 (2026-06-30 weekly meeting)
We'll see whoever's available at the time.
6:55
S…
Speaker 2 (2026-06-30 weekly meeting)
Okay.
7:02
S…
Speaker 3 (2026-06-30 weekly meeting)
And then here is a new update.
7:07
S…
Speaker 3 (2026-06-30 weekly meeting)
And we discussed on today's working
7:11
S…
Speaker 3 (2026-06-30 weekly meeting)
session in ADK.
7:12
S…
Speaker 3 (2026-06-30 weekly meeting)
So we should update
7:16
S…
Speaker 3 (2026-06-30 weekly meeting)
the DI and IFU for the studies for
7:20
S…
Speaker 1 (2026-06-30 weekly meeting)
SHAKAS.
7:21
S…
Speaker 3 (2026-06-30 weekly meeting)
like Interferring and Curse Reactivity and LOD
7:26
S…
Speaker 2 (2026-06-30 weekly meeting)
tests.
7:26
S…
Speaker 3 (2026-06-30 weekly meeting)
But we discussed CR should
7:31
S…
Speaker 3 (2026-06-30 weekly meeting)
be opened for the updates because these
7:35
S…
Speaker 3 (2026-06-30 weekly meeting)
are not for getting the same mark.
7:40
S…
Speaker 2 (2026-06-30 weekly meeting)
Yes,
7:40
S…
Speaker 1 (2026-06-30 weekly meeting)
yes.
7:41
S…
Speaker 4 (2026-06-30 weekly meeting)
Okay, I agree.
7:42
S…
Speaker 4 (2026-06-30 weekly meeting)
Because it falls after,
7:43
S…
Speaker 4 (2026-06-30 weekly meeting)
it cannot fall within the submission CR.
7:45
S…
Speaker 4 (2026-06-30 weekly meeting)
I think that's a correct interpretation.
7:48
S…
Speaker 2 (2026-06-30 weekly meeting)
Yes.
7:48
S…
Speaker 3 (2026-06-30 weekly meeting)
So we will open the CR for these
7:53
S…
Speaker 3 (2026-06-30 weekly meeting)
document updates.
7:54
S…
Speaker 3 (2026-06-30 weekly meeting)
But in here,
7:57
S…
Speaker 3 (2026-06-30 weekly meeting)
we discussed the DI and
8:01
S…
Speaker 3 (2026-06-30 weekly meeting)
IFU, the scope.
8:02
S…
Speaker 2 (2026-06-30 weekly meeting)
Especially,
8:04
S…
Speaker 3 (2026-06-30 weekly meeting)
we should update the IVDR,
8:08
S…
Speaker 3 (2026-06-30 weekly meeting)
IFU.
8:11
S…
Speaker 3 (2026-06-30 weekly meeting)
Could we update the IVDD as well?
8:15
S…
Speaker 3 (2026-06-30 weekly meeting)
But from the RA opinions,
8:18
S…
Speaker 3 (2026-06-30 weekly meeting)
maybe the country
8:24
S…
Speaker 3 (2026-06-30 weekly meeting)
registration leads
8:28
S…
Speaker 3 (2026-06-30 weekly meeting)
to two years for,
8:30
S…
Speaker 2 (2026-06-30 weekly meeting)
for example,
8:30
S…
Speaker 1 (2026-06-30 weekly meeting)
Mexico.
8:31
S…
Speaker 3 (2026-06-30 weekly meeting)
So maybe after two years.
8:34
S…
Speaker 2 (2026-06-30 weekly meeting)
Yeah,
8:35
S…
Speaker 4 (2026-06-30 weekly meeting)
so the IVDD does not get updated.
8:39
S…
Speaker 4 (2026-06-30 weekly meeting)
No more changes to IVDD product.
8:43
S…
Speaker 3 (2026-06-30 weekly meeting)
Yeah, but we need one more discussion on Thursday working
8:48
S…
Speaker 3 (2026-06-30 weekly meeting)
session and then I can update
8:52
S…
Speaker 2 (2026-06-30 weekly meeting)
you on PMO meeting.
8:55
S…
Speaker 1 (2026-06-30 weekly meeting)
so yeah hi i mean i agree with that because that
8:59
S…
Speaker 1 (2026-06-30 weekly meeting)
uh for the the ivdd the when we
9:04
S…
Speaker 1 (2026-06-30 weekly meeting)
have a discussion with the commercial array because it
9:08
S…
Speaker 1 (2026-06-30 weekly meeting)
might be confusing the timeline perspective and the other change perspective
9:12
S…
Speaker 1 (2026-06-30 weekly meeting)
and as much as possible we will update
9:16
S…
Speaker 1 (2026-06-30 weekly meeting)
with i visual transition and we try to avoid that
9:20
S…
Speaker 1 (2026-06-30 weekly meeting)
additional ivdd change before i video transition
9:24
S…
Speaker 2 (2026-06-30 weekly meeting)
That's it.
9:24
S…
Speaker 1 (2026-06-30 weekly meeting)
That was our strategy.
9:26
S…
Speaker 2 (2026-06-30 weekly meeting)
Yes,
9:27
S…
Speaker 4 (2026-06-30 weekly meeting)
I agree with that.
9:28
S…
Speaker 1 (2026-06-30 weekly meeting)
Yeah.
9:28
S…
Speaker 2 (2026-06-30 weekly meeting)
Yes.
9:30
S…
Speaker 2 (2026-06-30 weekly meeting)
So,
9:33
S…
Speaker 3 (2026-06-30 weekly meeting)
there is no more updates for Shagas.
9:38
S…
Speaker 4 (2026-06-30 weekly meeting)
Okay, so this is good news.
9:39
S…
Speaker 4 (2026-06-30 weekly meeting)
Once the SSP is back,
9:41
S…
Speaker 4 (2026-06-30 weekly meeting)
I believe we will proceed very quickly to certification.
9:44
S…
Speaker 4 (2026-06-30 weekly meeting)
Young,
9:45
S…
Speaker 4 (2026-06-30 weekly meeting)
just so that you know,
9:46
S…
Speaker 4 (2026-06-30 weekly meeting)
they have confirmed with me that because the
9:50
S…
Speaker 4 (2026-06-30 weekly meeting)
QMS cert already contains the relevant codes that we do not need to add
9:55
S…
Speaker 4 (2026-06-30 weekly meeting)
enough change notification to update that.
9:57
S…
Speaker 4 (2026-06-30 weekly meeting)
So it's basically going to be...
10:00
S…
Speaker 3 (2026-06-30 weekly meeting)
the issuance of the TDAR,
10:02
S…
Speaker 3 (2026-06-30 weekly meeting)
which is the Technical Document Assessment Report,
10:04
S…
Speaker 3 (2026-06-30 weekly meeting)
which closes the deficiency rounds.
10:06
S…
Speaker 3 (2026-06-30 weekly meeting)
Once that's done,
10:07
S…
Speaker 3 (2026-06-30 weekly meeting)
then this product is considered certified.
10:10
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay,
10:12
S…
Speaker 1 (2026-06-30 weekly meeting)
thank you.
10:12
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay,
10:17
S…
Speaker 1 (2026-06-30 weekly meeting)
if there is no opinion for two products,
10:21
S…
Speaker 1 (2026-06-30 weekly meeting)
maybe I can move on to Rotarino.
10:24
S…
Speaker 3 (2026-06-30 weekly meeting)
Thank you.
10:31
S…
Speaker 2 (2026-06-30 weekly meeting)
So for Tardino,
10:34
S…
Speaker 2 (2026-06-30 weekly meeting)
our IFU and labels for artwork.
10:38
S…
Speaker 2 (2026-06-30 weekly meeting)
So our artwork is now implemented.
10:41
S…
Speaker 2 (2026-06-30 weekly meeting)
Congratulations.
10:42
S…
Speaker 2 (2026-06-30 weekly meeting)
So finally it is implemented
10:46
S…
Speaker 2 (2026-06-30 weekly meeting)
so we can proceed for other dependent
10:51
S…
Speaker 2 (2026-06-30 weekly meeting)
documents like technical documents
10:55
S…
Speaker 2 (2026-06-30 weekly meeting)
or risk management files.
10:57
S…
Speaker 2 (2026-06-30 weekly meeting)
So we can right now move on to the next.
11:03
S…
Speaker 1 (2026-06-30 weekly meeting)
So,
11:03
S…
Speaker 1 (2026-06-30 weekly meeting)
first of all,
11:05
S…
Speaker 2 (2026-06-30 weekly meeting)
inspection protocol will be implemented after the
11:09
S…
Speaker 2 (2026-06-30 weekly meeting)
review of the report.
11:10
S…
Speaker 2 (2026-06-30 weekly meeting)
So, for the inspection protocol,
11:14
S…
Speaker 2 (2026-06-30 weekly meeting)
all approvals are in your department,
11:18
S…
Speaker 2 (2026-06-30 weekly meeting)
so it can be approved within one day.
11:20
S…
Speaker 2 (2026-06-30 weekly meeting)
So, it's okay.
11:23
S…
Speaker 2 (2026-06-30 weekly meeting)
And for PP and APR,
11:27
S…
Speaker 2 (2026-06-30 weekly meeting)
it is planning to complete its
11:31
S…
Speaker 2 (2026-06-30 weekly meeting)
collaboration stage by tomorrow.
11:33
S…
Speaker 2 (2026-06-30 weekly meeting)
So I just added Bruce,
11:37
S…
Speaker 1 (2026-06-30 weekly meeting)
Robert Bruce,
11:38
S…
Speaker 2 (2026-06-30 weekly meeting)
in our email chain from today,
11:42
S…
Speaker 2 (2026-06-30 weekly meeting)
so he could inform another event.
11:44
S…
Speaker 2 (2026-06-30 weekly meeting)
So there is two updates for our approval
11:50
S…
Speaker 1 (2026-06-30 weekly meeting)
timeline.
11:54
S…
Speaker 2 (2026-06-30 weekly meeting)
technical memo to be attached
11:58
S…
Speaker 2 (2026-06-30 weekly meeting)
to ATR.
12:01
S…
Speaker 2 (2026-06-30 weekly meeting)
So we need this technical memo
12:05
S…
Speaker 2 (2026-06-30 weekly meeting)
approval and that memo will be approved.
12:10
S…
Speaker 2 (2026-06-30 weekly meeting)
by July 2nd.
12:12
S…
Speaker 2 (2026-06-30 weekly meeting)
So the collaboration should be conducted after this
12:16
S…
Speaker 2 (2026-06-30 weekly meeting)
technical memo implementation.
12:18
S…
Speaker 2 (2026-06-30 weekly meeting)
So the collaboration deadline will be changed
12:22
S…
Speaker 2 (2026-06-30 weekly meeting)
to July 7th.
12:24
S…
Speaker 2 (2026-06-30 weekly meeting)
So that's
12:29
S…
Speaker 2 (2026-06-30 weekly meeting)
this one.
12:32
S…
Speaker 2 (2026-06-30 weekly meeting)
So we are originally planned for,
12:36
S…
Speaker 2 (2026-06-30 weekly meeting)
I'm not really sure about the third.
12:44
S…
Speaker 2 (2026-06-30 weekly meeting)
So we are planning to end
12:48
S…
Speaker 2 (2026-06-30 weekly meeting)
the collaboration on 2nd of July,
12:51
S…
Speaker 2 (2026-06-30 weekly meeting)
but it is maybe the same date of the so -called
12:55
S…
Speaker 2 (2026-06-30 weekly meeting)
final approval date.
12:56
S…
Speaker 2 (2026-06-30 weekly meeting)
So we can wrap up our collaboration stage by
13:00
S…
Speaker 2 (2026-06-30 weekly meeting)
7th and move on to the final approval date and can
13:05
S…
Speaker 2 (2026-06-30 weekly meeting)
implement by 9th.
13:08
S…
Speaker 2 (2026-06-30 weekly meeting)
So that's one of the updates.
13:11
S…
Speaker 2 (2026-06-30 weekly meeting)
And for the PER and RMR,
13:15
S…
Speaker 2 (2026-06-30 weekly meeting)
the TO had reviewed these documents
13:19
S…
Speaker 2 (2026-06-30 weekly meeting)
and it was satisfied that a conclusion of RMR
13:23
S…
Speaker 2 (2026-06-30 weekly meeting)
should be linked into the PER.
13:32
S…
Speaker 1 (2026-06-30 weekly meeting)
Where is it?
13:33
S…
Speaker 2 (2026-06-30 weekly meeting)
Our original plan is to implement this
13:38
S…
Speaker 2 (2026-06-30 weekly meeting)
group of documents first and next we move
13:42
S…
Speaker 2 (2026-06-30 weekly meeting)
on to this document group.
13:44
S…
Speaker 2 (2026-06-30 weekly meeting)
But it is identified that if RMI
13:48
S…
Speaker 2 (2026-06-30 weekly meeting)
should be implemented first,
13:50
S…
Speaker 2 (2026-06-30 weekly meeting)
that means PDR cannot implement this.
13:55
S…
Speaker 2 (2026-06-30 weekly meeting)
before RMR implementation.
13:58
S…
Speaker 2 (2026-06-30 weekly meeting)
So our target date has been changed to the same
14:02
S…
Speaker 2 (2026-06-30 weekly meeting)
date of the other document
14:07
S…
Speaker 2 (2026-06-30 weekly meeting)
groups.
14:08
S…
Speaker 2 (2026-06-30 weekly meeting)
So that's why we have updated
14:12
S…
Speaker 2 (2026-06-30 weekly meeting)
this timeline.
14:14
S…
Speaker 2 (2026-06-30 weekly meeting)
And this will be shared as daily
14:18
S…
Speaker 2 (2026-06-30 weekly meeting)
routine in tomorrow morning,
14:21
S…
Speaker 2 (2026-06-30 weekly meeting)
Korean time.
14:24
S…
Speaker 2 (2026-06-30 weekly meeting)
From now on everything alright?
14:27
S…
Speaker 1 (2026-06-30 weekly meeting)
That looks
14:32
S…
Speaker 3 (2026-06-30 weekly meeting)
good. As long as you can maintain that.
14:33
S…
Speaker 3 (2026-06-30 weekly meeting)
So the
14:38
S…
Speaker 2 (2026-06-30 weekly meeting)
implementation deadline has unchanged it so
14:42
S…
Speaker 2 (2026-06-30 weekly meeting)
we can move on on our original plan.
14:46
S…
Speaker 2 (2026-06-30 weekly meeting)
some kind of detailed due date has been changed
14:50
S…
Speaker 2 (2026-06-30 weekly meeting)
but it's not impacted in our submission due date so it's
14:55
S…
Speaker 2 (2026-06-30 weekly meeting)
okay i think we can handle it so that for tadina
14:59
S…
Speaker 2 (2026-06-30 weekly meeting)
update for club media so i saw your
15:03
S…
Speaker 2 (2026-06-30 weekly meeting)
emails and and i have some
15:08
S…
Speaker 2 (2026-06-30 weekly meeting)
review with to department and i
15:12
S…
Speaker 2 (2026-06-30 weekly meeting)
already sent you email
15:15
S…
Speaker 2 (2026-06-30 weekly meeting)
about the detailed information.
15:17
S…
Speaker 2 (2026-06-30 weekly meeting)
So,
15:18
S…
Speaker 2 (2026-06-30 weekly meeting)
I believe you already take a look for it.
15:22
S…
Speaker 2 (2026-06-30 weekly meeting)
So, we need to align a
15:26
S…
Speaker 2 (2026-06-30 weekly meeting)
clear scope of verification study first,
15:29
S…
Speaker 2 (2026-06-30 weekly meeting)
and then we can move on to the,
15:33
S…
Speaker 2 (2026-06-30 weekly meeting)
move on to the sample procedure,
15:35
S…
Speaker 2 (2026-06-30 weekly meeting)
measurement,
15:36
S…
Speaker 2 (2026-06-30 weekly meeting)
and lab build,
15:37
S…
Speaker 2 (2026-06-30 weekly meeting)
because after we can
15:43
S…
Speaker 2 (2026-06-30 weekly meeting)
we can say what we are going to do,
15:47
S…
Speaker 2 (2026-06-30 weekly meeting)
then we can know how much materials we
15:51
S…
Speaker 2 (2026-06-30 weekly meeting)
are required.
15:53
S…
Speaker 2 (2026-06-30 weekly meeting)
So that should be conducted
15:58
S…
Speaker 2 (2026-06-30 weekly meeting)
first.
15:58
S…
Speaker 2 (2026-06-30 weekly meeting)
And so that the earliest phase
16:03
S…
Speaker 2 (2026-06-30 weekly meeting)
of action with the sample for schema and rapid date
16:07
S…
Speaker 2 (2026-06-30 weekly meeting)
will be October.
16:08
S…
Speaker 2 (2026-06-30 weekly meeting)
So it is confirmed with Sunghee from TO.
16:13
S…
Speaker 2 (2026-06-30 weekly meeting)
than our timeline will look like this.
16:16
S…
Speaker 3 (2026-06-30 weekly meeting)
I'm
16:20
S…
Speaker 3 (2026-06-30 weekly meeting)
just looking at it side by side now.
16:23
S…
Speaker 3 (2026-06-30 weekly meeting)
Yes,
16:25
S…
Speaker 3 (2026-06-30 weekly meeting)
that looks substantially better.
16:26
S…
Speaker 1 (2026-06-30 weekly meeting)
They were,
16:27
S…
Speaker 3 (2026-06-30 weekly meeting)
Andrea was concerned that...
16:29
S…
Speaker 3 (2026-06-30 weekly meeting)
Anyone who reviews that will only see 20 -30 and not
16:33
S…
Speaker 3 (2026-06-30 weekly meeting)
really understand what builds up to that.
16:37
S…
Speaker 3 (2026-06-30 weekly meeting)
So what I explained to her is that it is likely that these can be
16:41
S…
Speaker 3 (2026-06-30 weekly meeting)
pulled in to be as parallel as possible,
16:43
S…
Speaker 3 (2026-06-30 weekly meeting)
which is what I can see you did here.
16:45
S…
Speaker 3 (2026-06-30 weekly meeting)
And the important thing is that we try and maintain that
16:49
S…
Speaker 2 (2026-06-30 weekly meeting)
red line.
16:51
S…
Speaker 3 (2026-06-30 weekly meeting)
i think the concern that will still be presented is the implementation
16:55
S…
Speaker 3 (2026-06-30 weekly meeting)
risk as without the final stability studies they already
17:00
S…
Speaker 3 (2026-06-30 weekly meeting)
foresee some some problems with onward registrations if that's not available
17:04
S…
Speaker 3 (2026-06-30 weekly meeting)
so the fact that that's pulled into well it is very close
17:08
S…
Speaker 3 (2026-06-30 weekly meeting)
to the end of 2028 like that's not a lot better right
17:12
S…
Speaker 3 (2026-06-30 weekly meeting)
Yeah, it just reduces the risk.
17:14
S…
Speaker 3 (2026-06-30 weekly meeting)
But this is better.
17:15
S…
Speaker 3 (2026-06-30 weekly meeting)
So let me discuss this with her as an alternate timeline.
17:19
S…
Speaker 3 (2026-06-30 weekly meeting)
And if she has any further questions,
17:20
S…
Speaker 3 (2026-06-30 weekly meeting)
I'll get back to you.
17:21
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay,
17:22
S…
Speaker 2 (2026-06-30 weekly meeting)
so that's really good to hear.
17:26
S…
Speaker 2 (2026-06-30 weekly meeting)
So that's all
17:31
S…
Speaker 2 (2026-06-30 weekly meeting)
I have prepared to share.
17:33
S…
Speaker 2 (2026-06-30 weekly meeting)
So I come for our
17:37
S…
Speaker 2 (2026-06-30 weekly meeting)
submission for product.
17:40
S…
Speaker 3 (2026-06-30 weekly meeting)
No, I think that's very good.
17:42
S…
Speaker 3 (2026-06-30 weekly meeting)
Thank you very much,
17:43
S…
Speaker 3 (2026-06-30 weekly meeting)
everyone, for trying to keep all these multiple timelines,
17:46
S…
Speaker 3 (2026-06-30 weekly meeting)
parallel timelines on track.
17:48
S…
Speaker 3 (2026-06-30 weekly meeting)
I understand there's a lot of other things also going on,
17:51
S…
Speaker 1 (2026-06-30 weekly meeting)
not just IVDR.
17:52
S…
Speaker 3 (2026-06-30 weekly meeting)
So thank you very much for your hard work on that.
17:55
S…
Speaker 3 (2026-06-30 weekly meeting)
For the RSV response,
17:58
S…
Speaker 3 (2026-06-30 weekly meeting)
I will say something out today and
18:02
S…
Speaker 3 (2026-06-30 weekly meeting)
copy in.
18:05
S…
Speaker 3 (2026-06-30 weekly meeting)
Jisoo, Hulam and Young,
18:07
S…
Speaker 3 (2026-06-30 weekly meeting)
just so that you all have eyes on the
18:11
S…
Speaker 3 (2026-06-30 weekly meeting)
response wording that we are going to put forward.
18:14
S…
Speaker 3 (2026-06-30 weekly meeting)
And we should have that resolved by the end of the week.
18:17
S…
Speaker 3 (2026-06-30 weekly meeting)
Then by the end of next week,
18:18
S…
Speaker 3 (2026-06-30 weekly meeting)
when that goes back,
18:19
S…
Speaker 3 (2026-06-30 weekly meeting)
we've got another product that's going to certification,
18:24
S…
Speaker 3 (2026-06-30 weekly meeting)
which is good news.
18:25
S…
Speaker 1 (2026-06-30 weekly meeting)
Yeah,
18:27
S…
Speaker 1 (2026-06-30 weekly meeting)
thank you.
18:28
S…
Speaker 1 (2026-06-30 weekly meeting)
All right,
18:32
S…
Speaker 3 (2026-06-30 weekly meeting)
there's nothing more from my side.
18:33
S…
Speaker 3 (2026-06-30 weekly meeting)
Alex,
18:34
S…
Speaker 3 (2026-06-30 weekly meeting)
Azratid,
18:35
S…
Speaker 3 (2026-06-30 weekly meeting)
I don't think you have anything from yours.
18:38
S…
Speaker 1 (2026-06-30 weekly meeting)
No, nothing for me.
18:40
S…
Speaker 1 (2026-06-30 weekly meeting)
Okay,
18:45
S…
Speaker 2 (2026-06-30 weekly meeting)
so then we will share today's
18:49
S…
Speaker 2 (2026-06-30 weekly meeting)
minutes through email.
18:51
S…
Speaker 2 (2026-06-30 weekly meeting)
So maybe this is all for today.
18:55
S…
Speaker 3 (2026-06-30 weekly meeting)
That sounds good.
18:57
S…
Speaker 3 (2026-06-30 weekly meeting)
Thank you very much for your time,
18:59
S…
Speaker 1 (2026-06-30 weekly meeting)
everybody.
18:59
S…
Speaker 1 (2026-06-30 weekly meeting)
Thank you.
19:02
S…
Speaker 1 (2026-06-30 weekly meeting)
Bye -bye.
Haec transcriptio a AI (recognitione automatica loci) generata est. Errores continere potest - contra audio originalem verificare ut criticum utentur. Politicae
Summa
Haec pagina de scriptura explicat, quae ad scripturam translativam pertinet.
Summa...
De hoc translatio scripsit.
Quod ad hoc adscriptum est, quod ad hoc adscriptum est, et adscriptum est.