260615 PMO Alignment

0:49

S… Speaker 1 (260615 PMO Alignment)

Good morning, ladies.

0:49

S… Speaker 1 (260615 PMO Alignment)

Hello.

0:50

S… Speaker 1 (260615 PMO Alignment)

Can you hear me okay?

0:53

S… Speaker 1 (260615 PMO Alignment)

Yes.

0:55

S… Speaker 1 (260615 PMO Alignment)

Yes.

0:55

S… Speaker 1 (260615 PMO Alignment)

Yes.

0:56

S… Speaker 3 (260615 PMO Alignment)

Hope you all had a good weekend.

0:59

S… Speaker 1 (260615 PMO Alignment)

I

1:03

S… Speaker 1 (260615 PMO Alignment)

have. Yeah,

1:05

S… Speaker 4 (260615 PMO Alignment)

me too.

1:05

S… Speaker 1 (260615 PMO Alignment)

Good.

1:10

S… Speaker 3 (260615 PMO Alignment)

I can see your screen.

1:11

S… Speaker 1 (260615 PMO Alignment)

Oh,

1:12

S… Speaker 2 (260615 PMO Alignment)

yes. So can I start with RSV

1:17

S… Speaker 1 (260615 PMO Alignment)

first?

1:17

S… Speaker 1 (260615 PMO Alignment)

Yeah.

1:18

S… Speaker 2 (260615 PMO Alignment)

For RSV,

1:20

S… Speaker 2 (260615 PMO Alignment)

we are waiting for the response from

1:24

S… Speaker 2 (260615 PMO Alignment)

the global.

1:29

S… Speaker 2 (260615 PMO Alignment)

So we are waiting for the device data.

1:32

S… Speaker 2 (260615 PMO Alignment)

This is the alternative

1:37

S… Speaker 2 (260615 PMO Alignment)

for BioLine RSV.

1:39

S… Speaker 2 (260615 PMO Alignment)

So is there any updates or do you guys find

1:43

S… Speaker 2 (260615 PMO Alignment)

the...

1:44

S… Speaker 2 (260615 PMO Alignment)

alternate to the products?

1:46

S… Speaker 3 (260615 PMO Alignment)

So they're working on this now.

1:48

S… Speaker 3 (260615 PMO Alignment)

I'm expecting them to finish probably tomorrow afternoon so maybe

1:53

S… Speaker 3 (260615 PMO Alignment)

by Wednesday we can have something for you.

1:55

S… Speaker 3 (260615 PMO Alignment)

And it's two updates.

1:57

S… Speaker 3 (260615 PMO Alignment)

It's one with the NPT and it's one about the European population.

2:01

S… Speaker 3 (260615 PMO Alignment)

So two separate updates but it's impacting the same document.

2:04

S… Speaker 3 (260615 PMO Alignment)

What you need to factor in is that we

2:08

S… Speaker 3 (260615 PMO Alignment)

will need to take what they are writing.

2:12

S… Speaker 3 (260615 PMO Alignment)

for this and make an update into the cpr and

2:16

S… Speaker 3 (260615 PMO Alignment)

only a minor update into the per conclusion so

2:21

S… Speaker 3 (260615 PMO Alignment)

it means both of those documents need to go through agile once they're ready i

2:26

S… Speaker 3 (260615 PMO Alignment)

think for your scheduling purposes let's aim to take

2:30

S… Speaker 3 (260615 PMO Alignment)

it to agile probably from thursday or friday

2:34

S… Speaker 3 (260615 PMO Alignment)

if we got in at the moment uh but

2:40

S… Speaker 2 (260615 PMO Alignment)

actually we have

2:43

S… Speaker 2 (260615 PMO Alignment)

timeline for updated CPR is this is from the

2:47

S… Speaker 2 (260615 PMO Alignment)

UFMA update and UFMA is

2:52

S… Speaker 2 (260615 PMO Alignment)

from IF address metrics.

2:54

S… Speaker 2 (260615 PMO Alignment)

So I think we can update in this timeline,

2:57

S… Speaker 1 (260615 PMO Alignment)

I think.

2:58

S… Speaker 1 (260615 PMO Alignment)

OK,

2:59

S… Speaker 3 (260615 PMO Alignment)

just maybe add a line for the PER as well.

3:03

S… Speaker 3 (260615 PMO Alignment)

Although it will only just be one line in the conclusion

3:07

S… Speaker 3 (260615 PMO Alignment)

they have to update,

3:08

S… Speaker 3 (260615 PMO Alignment)

we have to take it all the way through Agile again.

3:11

S… Speaker 2 (260615 PMO Alignment)

So for PER,

3:13

S… Speaker 2 (260615 PMO Alignment)

I think we can upload just documents when we receive the

3:17

S… Speaker 1 (260615 PMO Alignment)

documents.

3:18

S… Speaker 2 (260615 PMO Alignment)

But I think we need to update

3:22

S… Speaker 2 (260615 PMO Alignment)

the CPR and then Glovers need to update CPR.

3:26

S… Speaker 2 (260615 PMO Alignment)

So should we update later for

3:31

S… Speaker 2 (260615 PMO Alignment)

your updates?

3:32

S… Speaker 3 (260615 PMO Alignment)

So we'll make the updates.

3:36

S… Speaker 3 (260615 PMO Alignment)

I just, I need to ask them what document,

3:40

S… Speaker 3 (260615 PMO Alignment)

give me a second,

3:41

S… Speaker 3 (260615 PMO Alignment)

they are actually answering on Teams at the moment.

3:44

S… Speaker 3 (260615 PMO Alignment)

Let me just confirm with them.

3:45

S… Speaker 1 (260615 PMO Alignment)

Yeah,

3:46

S… Speaker 1 (260615 PMO Alignment)

sure. I'm

4:16

S… Speaker 3 (260615 PMO Alignment)

just going to wait for them to respond,

4:18

S… Speaker 3 (260615 PMO Alignment)

but I wonder...

4:21

S… Speaker 3 (260615 PMO Alignment)

I wonder if we should ask for the latest version of

4:25

S… Speaker 3 (260615 PMO Alignment)

the CPR and the PER that can be given to us.

4:29

S… Speaker 3 (260615 PMO Alignment)

So you could send us a link or you can put it in the folder.

4:32

S… Speaker 3 (260615 PMO Alignment)

Then they can make a physical update in there.

4:35

S… Speaker 3 (260615 PMO Alignment)

Then it's completed.

4:36

S… Speaker 3 (260615 PMO Alignment)

Then you can lift that off as the one that you physically take through

4:40

S… Speaker 1 (260615 PMO Alignment)

Agile.

4:41

S… Speaker 3 (260615 PMO Alignment)

How does that sound?

4:41

S… Speaker 1 (260615 PMO Alignment)

Should

4:46

S… Speaker 2 (260615 PMO Alignment)

we update for CPR and then we will update and

4:51

S… Speaker 2 (260615 PMO Alignment)

then we will unload the airtight?

4:55

S… Speaker 3 (260615 PMO Alignment)

I'm just asking he's saying here he's not making the red lines yet so

5:00

S… Speaker 2 (260615 PMO Alignment)

They're building standalone summaries first,

5:02

S… Speaker 2 (260615 PMO Alignment)

and then they have to go back into the CPR and PER to update.

5:05

S… Speaker 2 (260615 PMO Alignment)

So if we can get the CPR and PER,

5:09

S… Speaker 2 (260615 PMO Alignment)

you know, the current version,

5:11

S… Speaker 2 (260615 PMO Alignment)

the one that you want updated,

5:12

S… Speaker 2 (260615 PMO Alignment)

then let us make the update for you and give it back to you to

5:16

S… Speaker 1 (260615 PMO Alignment)

take too much to add them.

5:19

S… Speaker 3 (260615 PMO Alignment)

Okay,

5:20

S… Speaker 1 (260615 PMO Alignment)

I understand.

5:20

S… Speaker 3 (260615 PMO Alignment)

Thank you.

5:23

S… Speaker 1 (260615 PMO Alignment)

So just only CPR and PER

5:27

S… Speaker 1 (260615 PMO Alignment)

should be updates for ONLY or RSV?

5:33

S… Speaker 2 (260615 PMO Alignment)

Yes.

5:33

S… Speaker 1 (260615 PMO Alignment)

Okay,

5:35

S… Speaker 1 (260615 PMO Alignment)

I see.

5:35

S… Speaker 2 (260615 PMO Alignment)

Because the other document they're working on

5:39

S… Speaker 2 (260615 PMO Alignment)

is for part of the actual response,

5:42

S… Speaker 2 (260615 PMO Alignment)

which we know the notified body will accept,

5:45

S… Speaker 2 (260615 PMO Alignment)

but then the permanent position on this is updated

5:49

S… Speaker 2 (260615 PMO Alignment)

in the CPR,

5:50

S… Speaker 2 (260615 PMO Alignment)

the PR.

5:53

S… Speaker 1 (260615 PMO Alignment)

Okay.

5:53

S… Speaker 2 (260615 PMO Alignment)

So the action really is for educators just wait for us to then give them the

5:58

S… Speaker 2 (260615 PMO Alignment)

updated CPR and PER and then the approval chain can start.

6:02

S… Speaker 2 (260615 PMO Alignment)

But I think the timing works fine because you've only got it.

6:05

S… Speaker 2 (260615 PMO Alignment)

Could you bring up that timeline again?

6:08

S… Speaker 2 (260615 PMO Alignment)

I think it's next week that you're planning Agile,

6:11

S… Speaker 2 (260615 PMO Alignment)

right? Because of the other UFBA updates.

6:13

S… Speaker 3 (260615 PMO Alignment)

Yeah,

6:15

S… Speaker 2 (260615 PMO Alignment)

22, I think,

6:17

S… Speaker 2 (260615 PMO Alignment)

23, that's when you start going.

6:18

S… Speaker 1 (260615 PMO Alignment)

Okay.

6:19

S… Speaker 1 (260615 PMO Alignment)

Yeah.

6:20

S… Speaker 3 (260615 PMO Alignment)

Okay.

6:21

S… Speaker 2 (260615 PMO Alignment)

Timing works fine.

6:23

S… Speaker 1 (260615 PMO Alignment)

Okay, so if there

6:28

S… Speaker 1 (260615 PMO Alignment)

is no any updates from opening party stability,

6:31

S… Speaker 1 (260615 PMO Alignment)

maybe we will fix this schedule and

6:35

S… Speaker 1 (260615 PMO Alignment)

submission expected date is July 10th.

6:40

S… Speaker 3 (260615 PMO Alignment)

Okay,

6:42

S… Speaker 2 (260615 PMO Alignment)

let's go with,

6:43

S… Speaker 2 (260615 PMO Alignment)

so we are today 15.

6:46

S… Speaker 3 (260615 PMO Alignment)

Yeah.

6:48

S… Speaker 1 (260615 PMO Alignment)

Is it still,

6:49

S… Speaker 2 (260615 PMO Alignment)

10th is the earliest there.

6:54

S… Speaker 2 (260615 PMO Alignment)

Let's keep with the 10th.

6:56

S… Speaker 2 (260615 PMO Alignment)

Are we happy and confident with July 10th?

6:58

S… Speaker 2 (260615 PMO Alignment)

Can I communicate that to TUV?

7:01

S… Speaker 1 (260615 PMO Alignment)

But could I have

7:05

S… Speaker 1 (260615 PMO Alignment)

just one day?

7:06

S… Speaker 1 (260615 PMO Alignment)

Because we should decide the buffer name.

7:09

S… Speaker 1 (260615 PMO Alignment)

We are discussing now for that.

7:12

S… Speaker 1 (260615 PMO Alignment)

So if the buffer

7:17

S… Speaker 1 (260615 PMO Alignment)

name is changed,

7:18

S… Speaker 1 (260615 PMO Alignment)

maybe the impacted documents will be increased,

7:21

S… Speaker 1 (260615 PMO Alignment)

I think.

7:22

S… Speaker 1 (260615 PMO Alignment)

So I will update to you until tomorrow.

7:26

S… Speaker 3 (260615 PMO Alignment)

Okay.

7:27

S… Speaker 3 (260615 PMO Alignment)

All right.

7:29

S… Speaker 2 (260615 PMO Alignment)

I just want to see if we can.

7:33

S… Speaker 2 (260615 PMO Alignment)

You see the section between 17 to 23,

7:37

S… Speaker 2 (260615 PMO Alignment)

which says document after IFU.

7:39

S… Speaker 2 (260615 PMO Alignment)

And then also on CPR and PEI,

7:42

S… Speaker 2 (260615 PMO Alignment)

you've got document after CP.

7:44

S… Speaker 2 (260615 PMO Alignment)

Is that a document update or is that agile?

7:46

S… Speaker 1 (260615 PMO Alignment)

Just updates.

7:49

S… Speaker 2 (260615 PMO Alignment)

Okay, so seeing that my guys are going to do the CPR and PER

7:53

S… Speaker 2 (260615 PMO Alignment)

update,

7:54

S… Speaker 2 (260615 PMO Alignment)

can we see if we can take that right -hand block and move everything in a

7:58

S… Speaker 2 (260615 PMO Alignment)

week? I really want to go for early July as a

8:02

S… Speaker 2 (260615 PMO Alignment)

better date than 10 July.

8:04

S… Speaker 1 (260615 PMO Alignment)

Ah,

8:05

S… Speaker 1 (260615 PMO Alignment)

okay.

8:06

S… Speaker 2 (260615 PMO Alignment)

Is it possible?

8:08

S… Speaker 1 (260615 PMO Alignment)

I think maybe

8:14

S… Speaker 1 (260615 PMO Alignment)

July for one week.

8:16

S… Speaker 3 (260615 PMO Alignment)

Yeah,

8:18

S… Speaker 2 (260615 PMO Alignment)

if we go for...

8:23

S… Speaker 2 (260615 PMO Alignment)

you just check sorry let me just look at my calendar here because we

8:29

S… Speaker 2 (260615 PMO Alignment)

currently that one is going 10 i mean i want to try for 3 july um

8:33

S… Speaker 2 (260615 PMO Alignment)

have a look tomorrow seeing that it's not a significant amount

8:37

S… Speaker 2 (260615 PMO Alignment)

of changes right i don't want this to to go

8:42

S… Speaker 2 (260615 PMO Alignment)

out too long because we also have shagas that they're going to expect a response on um

8:46

S… Speaker 2 (260615 PMO Alignment)

shagas we can

8:50

S… Speaker 2 (260615 PMO Alignment)

We can argue delay.

8:51

S… Speaker 2 (260615 PMO Alignment)

We'll talk about it now.

8:52

S… Speaker 2 (260615 PMO Alignment)

But I think we should be able to get this done by the third.

8:55

S… Speaker 2 (260615 PMO Alignment)

But you don't have to tell me now.

8:57

S… Speaker 2 (260615 PMO Alignment)

Have a discussion with the team first and we can align tomorrow.

9:01

S… Speaker 1 (260615 PMO Alignment)

Yes.

9:02

S… Speaker 1 (260615 PMO Alignment)

Yes,

9:04

S… Speaker 1 (260615 PMO Alignment)

I already sent an email as I sent you.

9:07

S… Speaker 1 (260615 PMO Alignment)

If I'm getting any

9:11

S… Speaker 1 (260615 PMO Alignment)

updates, maybe I can update to you.

9:14

S… Speaker 1 (260615 PMO Alignment)

But in tomorrow's working session,

9:17

S… Speaker 1 (260615 PMO Alignment)

there is no...

9:18

S… Speaker 1 (260615 PMO Alignment)

TPS member so I can't maybe discuss about the

9:22

S… Speaker 1 (260615 PMO Alignment)

study timeline in tomorrow's

9:27

S… Speaker 1 (260615 PMO Alignment)

working session.

9:27

S… Speaker 1 (260615 PMO Alignment)

So I'm just waiting for getting the reply

9:32

S… Speaker 1 (260615 PMO Alignment)

from email.

9:33

S… Speaker 1 (260615 PMO Alignment)

So I'm not sure I can update you

9:37

S… Speaker 1 (260615 PMO Alignment)

in tomorrow's our weekly meeting.

9:41

S… Speaker 1 (260615 PMO Alignment)

I'm not sure.

9:44

S… Speaker 2 (260615 PMO Alignment)

So in weekly meeting,

9:45

S… Speaker 2 (260615 PMO Alignment)

I'm thinking again,

9:47

S… Speaker 2 (260615 PMO Alignment)

you know,

9:47

S… Speaker 2 (260615 PMO Alignment)

the information we're exchanging now is good.

9:49

S… Speaker 2 (260615 PMO Alignment)

I don't think anyone from the Center of T is going to give me additional answers or

9:54

S… Speaker 2 (260615 PMO Alignment)

input,

9:54

S… Speaker 2 (260615 PMO Alignment)

especially if we're saying someone from the team isn't

9:58

S… Speaker 1 (260615 PMO Alignment)

there.

10:00

S… Speaker 2 (260615 PMO Alignment)

I may cancel that again,

10:01

S… Speaker 2 (260615 PMO Alignment)

so they'd rather use that time to work on what they need to.

10:04

S… Speaker 2 (260615 PMO Alignment)

But I think we have,

10:07

S… Speaker 2 (260615 PMO Alignment)

generally speaking,

10:09

S… Speaker 2 (260615 PMO Alignment)

between RSV and Shadows,

10:10

S… Speaker 2 (260615 PMO Alignment)

right? We've got a plan.

10:11

S… Speaker 2 (260615 PMO Alignment)

There's minor things that we need to do to resolve it.

10:15

S… Speaker 2 (260615 PMO Alignment)

So if Sabine's out of office today,

10:18

S… Speaker 2 (260615 PMO Alignment)

I think if we can just

10:22

S… Speaker 2 (260615 PMO Alignment)

maybe send her an email.

10:25

S… Speaker 2 (260615 PMO Alignment)

Or I can send her an email,

10:26

S… Speaker 1 (260615 PMO Alignment)

actually.

10:27

S… Speaker 2 (260615 PMO Alignment)

Let me send her an email.

10:28

S… Speaker 2 (260615 PMO Alignment)

I'll take that.

10:29

S… Speaker 2 (260615 PMO Alignment)

She can respond to me.

10:32

S… Speaker 2 (260615 PMO Alignment)

So we could just get an idea.

10:34

S… Speaker 2 (260615 PMO Alignment)

And just so you can understand,

10:37

S… Speaker 2 (260615 PMO Alignment)

TOB has given us an option.

10:40

S… Speaker 2 (260615 PMO Alignment)

they would like to know where you think we can get a report

10:44

S… Speaker 2 (260615 PMO Alignment)

back to them,

10:45

S… Speaker 2 (260615 PMO Alignment)

if we can just confirm that,

10:46

S… Speaker 2 (260615 PMO Alignment)

then they may either go,

10:48

S… Speaker 2 (260615 PMO Alignment)

okay, let's just hold until the report comes back and then we'll give the certificate.

10:52

S… Speaker 2 (260615 PMO Alignment)

Or if,

10:54

S… Speaker 2 (260615 PMO Alignment)

for example,

10:54

S… Speaker 2 (260615 PMO Alignment)

Sabine comes back and says,

10:56

S… Speaker 2 (260615 PMO Alignment)

we've got to fill the rises now,

10:58

S… Speaker 2 (260615 PMO Alignment)

but it's going to take additional two months,

11:00

S… Speaker 2 (260615 PMO Alignment)

we can only get the report back in August or later.

11:03

S… Speaker 2 (260615 PMO Alignment)

Then we might suggest to TUV,

11:06

S… Speaker 2 (260615 PMO Alignment)

can we conclude the conformity

11:10

S… Speaker 2 (260615 PMO Alignment)

assessment and do a final line project?

11:12

S… Speaker 2 (260615 PMO Alignment)

So we really need to have an answer on when we think

11:16

S… Speaker 2 (260615 PMO Alignment)

we can now get the final report to then share with TUV

11:20

S… Speaker 2 (260615 PMO Alignment)

so that we can determine the next pathway for

11:24

S… Speaker 2 (260615 PMO Alignment)

the certification.

11:26

S… Speaker 3 (260615 PMO Alignment)

So in here I have two questions.

11:28

S… Speaker 3 (260615 PMO Alignment)

The first one is,

11:30

S… Speaker 3 (260615 PMO Alignment)

can we submit the interim reports

11:35

S… Speaker 3 (260615 PMO Alignment)

without Filaria SIS sample?

11:37

S… Speaker 1 (260615 PMO Alignment)

Have we got that already?

11:40

S… Speaker 1 (260615 PMO Alignment)

We will get,

11:43

S… Speaker 3 (260615 PMO Alignment)

but we are not sure when we can get that sample.

11:49

S… Speaker 2 (260615 PMO Alignment)

It could be a possibility,

11:51

S… Speaker 2 (260615 PMO Alignment)

yes.

11:52

S… Speaker 2 (260615 PMO Alignment)

But I think let's give the answer first

11:56

S… Speaker 2 (260615 PMO Alignment)

so we can understand what kind of timeline we're talking about for filler rises.

12:00

S… Speaker 2 (260615 PMO Alignment)

And then we'll see what is the best.

12:03

S… Speaker 2 (260615 PMO Alignment)

combination we can go back with either wait for everything or wait

12:07

S… Speaker 2 (260615 PMO Alignment)

for the bulk of them and submit an interim report and then

12:11

S… Speaker 2 (260615 PMO Alignment)

maybe do a follow -up just for filariasis or do we want to do a follow -up for everything

12:15

S… Speaker 2 (260615 PMO Alignment)

so there's quite a few options on the table but it all pivots around filariasis

12:20

S… Speaker 2 (260615 PMO Alignment)

so let's just get a firm understanding on that first and then you can see

12:24

S… Speaker 1 (260615 PMO Alignment)

which way and

12:34

S… Speaker 3 (260615 PMO Alignment)

Sevin will update the timeline for sample

12:38

S… Speaker 3 (260615 PMO Alignment)

sourcing.

12:39

S… Speaker 3 (260615 PMO Alignment)

Second question is

12:43

S… Speaker 3 (260615 PMO Alignment)

about how long does it take to certificate

12:48

S… Speaker 3 (260615 PMO Alignment)

CE mark from submission of

12:52

S… Speaker 3 (260615 PMO Alignment)

DR2?

12:56

S… Speaker 2 (260615 PMO Alignment)

um well it's not a certain thing right uh but

13:01

S… Speaker 2 (260615 PMO Alignment)

i i reckon we anything from four to eight

13:05

S… Speaker 2 (260615 PMO Alignment)

weeks is what you need to anticipate this

13:09

S… Speaker 2 (260615 PMO Alignment)

one this one is a bit different

13:13

S… Speaker 2 (260615 PMO Alignment)

shagas shagas isn't a product certificate

13:17

S… Speaker 2 (260615 PMO Alignment)

it's professional use only right um therefore it

13:21

S… Speaker 2 (260615 PMO Alignment)

is the qms certificate that gets updated it's not a product certificate so

13:26

S… Speaker 2 (260615 PMO Alignment)

it might it might go a little faster

13:29

S… Speaker 1 (260615 PMO Alignment)

Oh, I see.

13:32

S… Speaker 5 (260615 PMO Alignment)

Okay.

13:34

S… Speaker 2 (260615 PMO Alignment)

But we're basically,

13:37

S… Speaker 2 (260615 PMO Alignment)

we're looking good on the timelines.

13:39

S… Speaker 2 (260615 PMO Alignment)

The fact that they've accepted everything else is very good news,

13:42

S… Speaker 2 (260615 PMO Alignment)

right? So this is just a formality with the interfering substances now.

13:45

S… Speaker 5 (260615 PMO Alignment)

Yes.

13:49

S… Speaker 5 (260615 PMO Alignment)

Yes.

13:51

S… Speaker 3 (260615 PMO Alignment)

But the reason why I ask you,

13:54

S… Speaker 3 (260615 PMO Alignment)

this timeline is a little bit changed of the

13:59

S… Speaker 3 (260615 PMO Alignment)

previous timeline.

14:02

S… Speaker 3 (260615 PMO Alignment)

I just ask you,

14:04

S… Speaker 3 (260615 PMO Alignment)

and the C mark is,

14:05

S… Speaker 3 (260615 PMO Alignment)

we can get the C mark,

14:08

S… Speaker 1 (260615 PMO Alignment)

but can we,

14:10

S… Speaker 3 (260615 PMO Alignment)

we can just wait.

14:12

S… Speaker 2 (260615 PMO Alignment)

I see the CE.

14:13

S… Speaker 2 (260615 PMO Alignment)

You've got CE estimate in October there.

14:16

S… Speaker 2 (260615 PMO Alignment)

It'll definitely be sooner.

14:18

S… Speaker 2 (260615 PMO Alignment)

I reckon,

14:19

S… Speaker 1 (260615 PMO Alignment)

I mean,

14:21

S… Speaker 2 (260615 PMO Alignment)

September is probably your safest bet,

14:23

S… Speaker 2 (260615 PMO Alignment)

but I reckon we'll get it by August.

14:26

S… Speaker 1 (260615 PMO Alignment)

Oh,

14:27

S… Speaker 1 (260615 PMO Alignment)

okay.

14:28

S… Speaker 3 (260615 PMO Alignment)

Thank you.

14:31

S… Speaker 3 (260615 PMO Alignment)

So that's all for RSV and SAGAS.

14:34

S… Speaker 3 (260615 PMO Alignment)

So if there is no comment for this,

14:37

S… Speaker 3 (260615 PMO Alignment)

maybe we can move on to Rotadino.

14:41

S… Speaker 2 (260615 PMO Alignment)

Nothing more from me.

14:43

S… Speaker 1 (260615 PMO Alignment)

Yes,

14:44

S… Speaker 4 (260615 PMO Alignment)

let's just then let's move on to

14:48

S… Speaker 4 (260615 PMO Alignment)

the Rotadino.

14:50

S… Speaker 4 (260615 PMO Alignment)

And unfortunately,

14:52

S… Speaker 4 (260615 PMO Alignment)

there is few things I have

14:56

S… Speaker 2 (260615 PMO Alignment)

to, I have so.

15:00

S… Speaker 2 (260615 PMO Alignment)

We already discussed about the MDF

15:04

S… Speaker 2 (260615 PMO Alignment)

update, which is originally DMR.

15:07

S… Speaker 2 (260615 PMO Alignment)

So we have changed original

15:12

S… Speaker 2 (260615 PMO Alignment)

CR onto the collaboration stage,

15:15

S… Speaker 2 (260615 PMO Alignment)

and we added Rotadino

15:19

S… Speaker 2 (260615 PMO Alignment)

project only,

15:21

S… Speaker 2 (260615 PMO Alignment)

and we are doing collaboration.

15:25

S… Speaker 2 (260615 PMO Alignment)

final approval again but some of requests for

15:29

S… Speaker 2 (260615 PMO Alignment)

the change request form updates continue

15:34

S… Speaker 2 (260615 PMO Alignment)

to occur so some acknowledgement is being

15:38

S… Speaker 2 (260615 PMO Alignment)

delayed so now is it is still on collaboration stage

15:42

S… Speaker 2 (260615 PMO Alignment)

so this is the bad news and we

15:50

S… Speaker 2 (260615 PMO Alignment)

targeted to release this CR on

15:54

S… Speaker 2 (260615 PMO Alignment)

last Friday but you know this today

15:58

S… Speaker 2 (260615 PMO Alignment)

is already Monday and we are waiting

16:02

S… Speaker 2 (260615 PMO Alignment)

for the CR release to have an action

16:06

S… Speaker 2 (260615 PMO Alignment)

for the MDF update so after the real CR

16:11

S… Speaker 2 (260615 PMO Alignment)

release we can update the MDF after MDF have

16:15

S… Speaker 2 (260615 PMO Alignment)

implemented we can

16:18

S… Speaker 2 (260615 PMO Alignment)

update the IFU and after that all of our

16:22

S… Speaker 2 (260615 PMO Alignment)

documents can move forward.

16:24

S… Speaker 2 (260615 PMO Alignment)

So this is our block card right now.

16:28

S… Speaker 1 (260615 PMO Alignment)

Do you need any help for me to escalate

16:32

S… Speaker 1 (260615 PMO Alignment)

anything with individuals taking a bit of time to

16:36

S… Speaker 1 (260615 PMO Alignment)

move the acknowledgements forward?

16:39

S… Speaker 2 (260615 PMO Alignment)

So I think Ali can help for it.

16:43

S… Speaker 2 (260615 PMO Alignment)

So let me discuss about with Ali

16:47

S… Speaker 2 (260615 PMO Alignment)

internal first.

16:48

S… Speaker 2 (260615 PMO Alignment)

If we need any further

16:53

S… Speaker 2 (260615 PMO Alignment)

help from your side,

16:54

S… Speaker 2 (260615 PMO Alignment)

I will ask for it.

16:55

S… Speaker 4 (260615 PMO Alignment)

OK,

16:58

S… Speaker 1 (260615 PMO Alignment)

I think.

16:59

S… Speaker 1 (260615 PMO Alignment)

I think we are at the stage where we need to start a daily email chain on

17:04

S… Speaker 1 (260615 PMO Alignment)

the sequence of events needed.

17:05

S… Speaker 1 (260615 PMO Alignment)

I just want to find the last time we did this.

17:09

S… Speaker 1 (260615 PMO Alignment)

I think it was for RSV or was it for Shagas?

17:11

S… Speaker 1 (260615 PMO Alignment)

I store them in my archives.

17:14

S… Speaker 1 (260615 PMO Alignment)

Give me a second.

17:15

S… Speaker 1 (260615 PMO Alignment)

I just want to look it up quickly for the approvals.

17:19

S… Speaker 4 (260615 PMO Alignment)

Yes,

17:22

S… Speaker 1 (260615 PMO Alignment)

I'm just going to share my screen for a moment.

17:24

S… Speaker 1 (260615 PMO Alignment)

Like this one.

17:28

S… Speaker 1 (260615 PMO Alignment)

Remember when we start,

17:29

S… Speaker 1 (260615 PMO Alignment)

because we're in the critical timing now,

17:31

S… Speaker 1 (260615 PMO Alignment)

where it really is important that people log on and make sure they've

17:36

S… Speaker 1 (260615 PMO Alignment)

got to go on to Agile and start following the approval chain,

17:38

S… Speaker 1 (260615 PMO Alignment)

where we had a table of whatever document it is,

17:41

S… Speaker 1 (260615 PMO Alignment)

what the CO number is,

17:43

S… Speaker 1 (260615 PMO Alignment)

who the driver is,

17:44

S… Speaker 1 (260615 PMO Alignment)

and the collaborators,

17:45

S… Speaker 1 (260615 PMO Alignment)

and the stages of each of these.

17:47

S… Speaker 1 (260615 PMO Alignment)

I think we even had it,

17:49

S… Speaker 1 (260615 PMO Alignment)

and I've clicked out of the...

17:52

S… Speaker 1 (260615 PMO Alignment)

like this.

17:53

S… Speaker 5 (260615 PMO Alignment)

Remember,

17:53

S… Speaker 1 (260615 PMO Alignment)

I can forward this again,

17:55

S… Speaker 1 (260615 PMO Alignment)

where we need to get people to really understand when's it

17:59

S… Speaker 1 (260615 PMO Alignment)

going to collaboration,

18:00

S… Speaker 1 (260615 PMO Alignment)

when must that collaboration be finished,

18:02

S… Speaker 1 (260615 PMO Alignment)

when's the final approval.

18:03

S… Speaker 1 (260615 PMO Alignment)

Because if I go look at our plan here,

18:06

S… Speaker 1 (260615 PMO Alignment)

we are now...

18:09

S… Speaker 1 (260615 PMO Alignment)

At the short end of the stick,

18:10

S… Speaker 1 (260615 PMO Alignment)

you know what I mean?

18:12

S… Speaker 1 (260615 PMO Alignment)

It's really getting urgent now.

18:15

S… Speaker 1 (260615 PMO Alignment)

So any delay we're getting more is going to very seriously compound

18:20

S… Speaker 1 (260615 PMO Alignment)

into the back here.

18:21

S… Speaker 1 (260615 PMO Alignment)

So I'm going to forward this one I just had on screen.

18:24

S… Speaker 1 (260615 PMO Alignment)

Please take that as a template.

18:26

S… Speaker 1 (260615 PMO Alignment)

And today already.

18:29

S… Speaker 1 (260615 PMO Alignment)

create a table like this and start listing them in the order they need to happen.

18:33

S… Speaker 1 (260615 PMO Alignment)

And hopefully if they're already in collaboration,

18:36

S… Speaker 1 (260615 PMO Alignment)

I know you won't have the name of the collaborators until it's actually live on agile,

18:40

S… Speaker 1 (260615 PMO Alignment)

but we need to start doing this and having everyone that

18:44

S… Speaker 1 (260615 PMO Alignment)

has a responsibility to sign in agile needs to be on this email chain.

18:48

S… Speaker 1 (260615 PMO Alignment)

And then we need to start doing this daily.

18:52

S… Speaker 1 (260615 PMO Alignment)

So we'll just say this is a daily week.

18:56

S… Speaker 1 (260615 PMO Alignment)

Just start the email introduction saying seeing that we are just we

19:00

S… Speaker 1 (260615 PMO Alignment)

have just over a month left to get this done,

19:02

S… Speaker 1 (260615 PMO Alignment)

right?

19:02

S… Speaker 1 (260615 PMO Alignment)

Then we are going to start a daily email chain just so people

19:06

S… Speaker 1 (260615 PMO Alignment)

could know what's coming to them in agile and we can keep track of the

19:10

S… Speaker 1 (260615 PMO Alignment)

status.

19:11

S… Speaker 1 (260615 PMO Alignment)

Each day to make sure that it's moving

19:15

S… Speaker 1 (260615 PMO Alignment)

along like it needs to.

19:16

S… Speaker 6 (260615 PMO Alignment)

Yes,

19:16

S… Speaker 2 (260615 PMO Alignment)

I think that's a really good table to share,

19:20

S… Speaker 2 (260615 PMO Alignment)

so I will.

19:21

S… Speaker 2 (260615 PMO Alignment)

I will appreciate if you can share that format with

19:25

S… Speaker 2 (260615 PMO Alignment)

me and I will do that

19:30

S… Speaker 3 (260615 PMO Alignment)

daily.

19:30

S… Speaker 2 (260615 PMO Alignment)

We are in urgent right now.

19:33

S… Speaker 1 (260615 PMO Alignment)

Thank

19:42

S… Speaker 1 (260615 PMO Alignment)

you so much.

19:46

S… Speaker 1 (260615 PMO Alignment)

You can take the screen back again.

19:54

S… Speaker 2 (260615 PMO Alignment)

That's all for our TED,

19:56

S… Speaker 2 (260615 PMO Alignment)

you know, so we are moving forward.

19:57

S… Speaker 2 (260615 PMO Alignment)

We have to moving forward,

19:58

S… Speaker 2 (260615 PMO Alignment)

but there is.

20:00

S… Speaker 1 (260615 PMO Alignment)

only one blocker with a CR so that's all for

20:04

S… Speaker 1 (260615 PMO Alignment)

Tarino and I will share the urgency

20:08

S… Speaker 1 (260615 PMO Alignment)

of

20:11

S… Speaker 1 (260615 PMO Alignment)

the collaboration stage through your table daily.

20:16

S… Speaker 1 (260615 PMO Alignment)

So yeah,

20:17

S… Speaker 1 (260615 PMO Alignment)

I would.

20:18

S… Speaker 2 (260615 PMO Alignment)

And make make sure I'm in in that email too,

20:20

S… Speaker 2 (260615 PMO Alignment)

because I'm also going to start each morning.

20:24

S… Speaker 2 (260615 PMO Alignment)

Now what I do is I tend to open agile and then I start looking at the status of

20:28

S… Speaker 2 (260615 PMO Alignment)

each of the CEOs and make sure that.

20:32

S… Speaker 2 (260615 PMO Alignment)

everyone who needs to sign off on any of those CEOs,

20:35

S… Speaker 2 (260615 PMO Alignment)

they're in this email change.

20:37

S… Speaker 2 (260615 PMO Alignment)

It will be a big one,

20:38

S… Speaker 2 (260615 PMO Alignment)

but that's the point,

20:39

S… Speaker 2 (260615 PMO Alignment)

right? We want everyone to know that these

20:44

S… Speaker 2 (260615 PMO Alignment)

are coming and they can't deny that they're not aware that it's coming.

20:47

S… Speaker 1 (260615 PMO Alignment)

Okay,

20:48

S… Speaker 1 (260615 PMO Alignment)

I will do that.

20:49

S… Speaker 1 (260615 PMO Alignment)

So that's all for Tadino.

21:10

S… Speaker 1 (260615 PMO Alignment)

So that's all for Talino and for Chlamydia.

21:13

S… Speaker 1 (260615 PMO Alignment)

So is there any updates first?

21:18

S… Speaker 2 (260615 PMO Alignment)

You won't believe how much pushback I'm getting from marketing.

21:22

S… Speaker 2 (260615 PMO Alignment)

It's insane.

21:23

S… Speaker 2 (260615 PMO Alignment)

I have to keep telling them in a different way the same story every time.

21:27

S… Speaker 2 (260615 PMO Alignment)

We shared additional

21:31

S… Speaker 2 (260615 PMO Alignment)

confirmation from Clinical,

21:34

S… Speaker 2 (260615 PMO Alignment)

who agrees with our position that we cannot proceed without gathering new data

21:39

S… Speaker 2 (260615 PMO Alignment)

because of the swabs and the requirement to prove equivalence.

21:42

S… Speaker 2 (260615 PMO Alignment)

But we're still getting pushback,

21:44

S… Speaker 2 (260615 PMO Alignment)

right? So we have put it in the SteerCo slides.

21:47

S… Speaker 2 (260615 PMO Alignment)

The functional SteerCo for IVDR is tomorrow.

21:49

S… Speaker 2 (260615 PMO Alignment)

We have a number of high -level functional managers on that call.

21:53

S… Speaker 2 (260615 PMO Alignment)

On that call,

21:54

S… Speaker 2 (260615 PMO Alignment)

once again,

21:55

S… Speaker 2 (260615 PMO Alignment)

we will try and...

21:59

S… Speaker 2 (260615 PMO Alignment)

agree what actions can the functional leaders

22:03

S… Speaker 2 (260615 PMO Alignment)

put in place to make a final decision about this.

22:06

S… Speaker 1 (260615 PMO Alignment)

OK,

22:07

S… Speaker 1 (260615 PMO Alignment)

so so there is quite maybe

22:11

S… Speaker 1 (260615 PMO Alignment)

a good news.

22:12

S… Speaker 1 (260615 PMO Alignment)

So our swap,

22:14

S… Speaker 1 (260615 PMO Alignment)

which was.

22:18

S… Speaker 2 (260615 PMO Alignment)

Is that Puritan the old or the new swap?

22:20

S… Speaker 1 (260615 PMO Alignment)

The new one.

22:21

S… Speaker 1 (260615 PMO Alignment)

So we are going to change into this Puritan swap,

22:26

S… Speaker 1 (260615 PMO Alignment)

which will be CE -certificated.

22:29

S… Speaker 1 (260615 PMO Alignment)

And Puritan swap has received the first approval for

22:33

S… Speaker 1 (260615 PMO Alignment)

CE mark,

22:34

S… Speaker 1 (260615 PMO Alignment)

but I have heard the final approval has not been received.

22:38

S… Speaker 1 (260615 PMO Alignment)

So they are not yet CE marked,

22:42

S… Speaker 1 (260615 PMO Alignment)

but they are moving forward to it.

22:46

S… Speaker 2 (260615 PMO Alignment)

personally i don't do we use them for do we use this for any other

22:50

S… Speaker 2 (260615 PMO Alignment)

products this puritan swap uh i believe no so

22:54

S… Speaker 1 (260615 PMO Alignment)

who is responsible for purchasing team,

22:58

S… Speaker 1 (260615 PMO Alignment)

the swap is responsible for Soohyuk.

23:02

S… Speaker 1 (260615 PMO Alignment)

And he said,

23:03

S… Speaker 1 (260615 PMO Alignment)

we don't have to proceed with new registration for

23:07

S… Speaker 1 (260615 PMO Alignment)

this fruit and swap if the chlamydia does not proceed to IVDR.

23:11

S… Speaker 1 (260615 PMO Alignment)

So if chlamydia product does not proceed,

23:15

S… Speaker 1 (260615 PMO Alignment)

we don't have to.

23:19

S… Speaker 2 (260615 PMO Alignment)

It sounds like it's only for chlamydia.

23:21

S… Speaker 1 (260615 PMO Alignment)

Yes.

23:21

S… Speaker 2 (260615 PMO Alignment)

It sounds like they only use it for that one.

23:24

S… Speaker 2 (260615 PMO Alignment)

I agree with that position,

23:26

S… Speaker 2 (260615 PMO Alignment)

right? So they're going to have to hold.

23:27

S… Speaker 2 (260615 PMO Alignment)

So good news,

23:28

S… Speaker 2 (260615 PMO Alignment)

I suppose, if we were going to go ahead.

23:30

S… Speaker 2 (260615 PMO Alignment)

But I mean, it's still the same problem because we don't have that traceability for

23:35

S… Speaker 2 (260615 PMO Alignment)

the old swabs.

23:35

S… Speaker 2 (260615 PMO Alignment)

We cannot prove equivalence without doing new studies and getting

23:39

S… Speaker 2 (260615 PMO Alignment)

new data using the new swabs.

23:41

S… Speaker 3 (260615 PMO Alignment)

Yes.

23:43

S… Speaker 1 (260615 PMO Alignment)

So that's...

23:47

S… Speaker 1 (260615 PMO Alignment)

That's all for my site also.

23:50

S… Speaker 1 (260615 PMO Alignment)

So that's all for our four products.

23:55

S… Speaker 1 (260615 PMO Alignment)

Any comments maybe?

23:56

S… Speaker 2 (260615 PMO Alignment)

Just same as last week,

23:59

S… Speaker 1 (260615 PMO Alignment)

right?

23:59

S… Speaker 2 (260615 PMO Alignment)

Do we need tomorrow's call then?

24:02

S… Speaker 2 (260615 PMO Alignment)

I would rather folks go into Agile,

24:04

S… Speaker 2 (260615 PMO Alignment)

use that hour to go through all of the Agile COs

24:08

S… Speaker 2 (260615 PMO Alignment)

that need to move on urgently than sit in the call that we don't need additional

24:12

S… Speaker 2 (260615 PMO Alignment)

information on.

24:14

S… Speaker 1 (260615 PMO Alignment)

So from my perspective,

24:16

S… Speaker 1 (260615 PMO Alignment)

Chlamydia is still on hold and Rotatino,

24:18

S… Speaker 1 (260615 PMO Alignment)

we are urgent for CEO and CR.

24:21

S… Speaker 1 (260615 PMO Alignment)

So I personally do not believe we will

24:25

S… Speaker 1 (260615 PMO Alignment)

need that session.

24:26

S… Speaker 1 (260615 PMO Alignment)

How about you,

24:27

S… Speaker 1 (260615 PMO Alignment)

Yukyeong?

24:30

S… Speaker 2 (260615 PMO Alignment)

Okay, I have a few of my guys can't make that session either,

24:33

S… Speaker 2 (260615 PMO Alignment)

so I'm going to cancel that,

24:35

S… Speaker 2 (260615 PMO Alignment)

but I'm going to explain that you will send out a status

24:39

S… Speaker 2 (260615 PMO Alignment)

email about the RSV,

24:42

S… Speaker 2 (260615 PMO Alignment)

sorry, the Rotadino Agile,

24:44

S… Speaker 2 (260615 PMO Alignment)

well,

24:46

S… Speaker 2 (260615 PMO Alignment)

the change orders,

24:47

S… Speaker 2 (260615 PMO Alignment)

and that I will ask everyone to take that

24:51

S… Speaker 2 (260615 PMO Alignment)

time to log in and proceed with as

24:56

S… Speaker 2 (260615 PMO Alignment)

many change orders as possible.

24:57

S… Speaker 3 (260615 PMO Alignment)

Okay.

25:00

S… Speaker 1 (260615 PMO Alignment)

So are you okay with that,

25:01

S… Speaker 1 (260615 PMO Alignment)

Yukyeong?

25:02

S… Speaker 3 (260615 PMO Alignment)

Yeah.

25:03

S… Speaker 1 (260615 PMO Alignment)

Yes.

25:04

S… Speaker 1 (260615 PMO Alignment)

So we are fully aligned.

260615 PMO Alignment

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