2026-06-30 weekly meeting

Jun 30, 2026 08:44 · 19:05 · English · Whisper Turbo · 4 གསལ་བཤད་

ཡིག་ཆ་འདི་ཕྱི་ཚེས་ ༡༥ ཉིན་མཇུག་བསྡུ་ནི་ཨིན་མས། གནས་བརྟན་གྱི་གནས་བཞག་གོང་འཕེལ་བཏང། →

སློབ་ཁྲིད་ཀྱི་ཐོ་

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.

ཡིག་སྒྱུར་འདི་ བཅོས་མའི་བློ་རིག་ (སྒྲ་ངོས་འཛིན་བྱེད་པའི་འཕྲུལ་རིག་) གིས་བཟོ་སྟེ་ཡོདཔ་ཨིན། འཛོལ་བ་འབྱུང་སྲིད་པ་ལ་ — གལ་སྲིད་ཁག་ཆེ་བའི་དོན་ལས་ ངོ་མ་གི་སྒྲ་སྐད་དང་འཕྱད་ཞིབ་འབད་དགོཔ་ཨིན། བཅོས་མའི་བློ་རིག་གི་སྲིད་བྱུས་

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