260602 Heat Map CR CO

1:37

S… Speaker 3 (260602 Heat Map CR CO)

Hey, good morning.

1:38

S… Speaker 2 (260602 Heat Map CR CO)

Hey,

1:40

S… Speaker 1 (260602 Heat Map CR CO)

good morning.

1:40

S… Speaker 1 (260602 Heat Map CR CO)

Good morning.

1:42

S… Speaker 3 (260602 Heat Map CR CO)

How are you all?

1:45

S… Speaker 1 (260602 Heat Map CR CO)

Yes,

1:46

S… Speaker 1 (260602 Heat Map CR CO)

fine.

1:47

S… Speaker 4 (260602 Heat Map CR CO)

How's it going there?

1:49

S… Speaker 2 (260602 Heat Map CR CO)

Good.

1:51

S… Speaker 3 (260602 Heat Map CR CO)

We had a bit of a break yesterday,

1:53

S… Speaker 3 (260602 Heat Map CR CO)

a day off.

1:54

S… Speaker 3 (260602 Heat Map CR CO)

So holiday here in Ireland.

1:58

S… Speaker 3 (260602 Heat Map CR CO)

I think Eve election day tomorrow?

2:01

S… Speaker 5 (260602 Heat Map CR CO)

Yes.

2:02

S… Speaker 2 (260602 Heat Map CR CO)

Is that right?

2:03

S… Speaker 3 (260602 Heat Map CR CO)

Okay.

2:04

S… Speaker 1 (260602 Heat Map CR CO)

So we have holiday tomorrow.

2:08

S… Speaker 3 (260602 Heat Map CR CO)

Yes.

2:09

S… Speaker 2 (260602 Heat Map CR CO)

Hello.

2:12

S… Speaker 3 (260602 Heat Map CR CO)

Nice break.

2:13

S… Speaker 3 (260602 Heat Map CR CO)

I love it.

2:16

S… Speaker 2 (260602 Heat Map CR CO)

I

2:23

S… Speaker 3 (260602 Heat Map CR CO)

think Anna said she'd be here in a couple of minutes.

2:27

S… Speaker 5 (260602 Heat Map CR CO)

Yes.

2:27

S… Speaker 4 (260602 Heat Map CR CO)

She left a challenge.

2:30

S… Speaker 1 (260602 Heat Map CR CO)

I think she will come soon.

2:34

S… Speaker 2 (260602 Heat Map CR CO)

Good

2:48

S… Speaker 1 (260602 Heat Map CR CO)

morning. Good morning.

2:50

S… Speaker 2 (260602 Heat Map CR CO)

Hey,

2:52

S… Speaker 1 (260602 Heat Map CR CO)

you're there.

2:54

S… Speaker 1 (260602 Heat Map CR CO)

hello good afternoon good

2:58

S… Speaker 4 (260602 Heat Map CR CO)

afternoon good morning everybody so i

3:06

S… Speaker 4 (260602 Heat Map CR CO)

think we can start now yep yep

3:10

S… Speaker 4 (260602 Heat Map CR CO)

so yes uh i

3:16

S… Speaker 4 (260602 Heat Map CR CO)

sent today's agenda yesterday via

3:20

S… Speaker 4 (260602 Heat Map CR CO)

email and

3:21

S… Speaker 4 (260602 Heat Map CR CO)

There is only a few things to share.

3:25

S… Speaker 4 (260602 Heat Map CR CO)

So as I said,

3:27

S… Speaker 4 (260602 Heat Map CR CO)

there are no major changes in the heat map for three

3:32

S… Speaker 4 (260602 Heat Map CR CO)

submission products.

3:34

S… Speaker 4 (260602 Heat Map CR CO)

So right now,

3:35

S… Speaker 4 (260602 Heat Map CR CO)

as you know,

3:36

S… Speaker 4 (260602 Heat Map CR CO)

Klamydia is on hold for this conclusion

3:41

S… Speaker 4 (260602 Heat Map CR CO)

for our marketing strategy.

3:43

S… Speaker 4 (260602 Heat Map CR CO)

So we are holding on for Klamydia.

3:47

S… Speaker 4 (260602 Heat Map CR CO)

So let's just focus on these three products.

3:52

S… Speaker 5 (260602 Heat Map CR CO)

Yes,

3:52

S… Speaker 4 (260602 Heat Map CR CO)

there are no major changes in the heat map.

3:55

S… Speaker 4 (260602 Heat Map CR CO)

However, we have found a new change that

3:59

S… Speaker 4 (260602 Heat Map CR CO)

medics

4:02

S… Speaker 4 (260602 Heat Map CR CO)

who manufactures for Rotadino's

4:07

S… Speaker 4 (260602 Heat Map CR CO)

antiviruses and

4:11

S… Speaker 4 (260602 Heat Map CR CO)

RSV's antiviruses.

4:13

S… Speaker 4 (260602 Heat Map CR CO)

They have site transfer from

4:18

S… Speaker 4 (260602 Heat Map CR CO)

US to Finland,

4:19

S… Speaker 4 (260602 Heat Map CR CO)

and also they will change in the manufacturing method

4:23

S… Speaker 4 (260602 Heat Map CR CO)

from in vivo to in vitro.

4:26

S… Speaker 4 (260602 Heat Map CR CO)

So these two changes are planned.

4:31

S… Speaker 4 (260602 Heat Map CR CO)

as i said the the scuff of this change

4:35

S… Speaker 4 (260602 Heat Map CR CO)

will affect both of ortodino and rsb

4:39

S… Speaker 4 (260602 Heat Map CR CO)

so a dcrp meeting is

4:44

S… Speaker 4 (260602 Heat Map CR CO)

planned for this change but the schedule has not

4:48

S… Speaker 4 (260602 Heat Map CR CO)

been confirmed so all we know is this

4:52

S… Speaker 4 (260602 Heat Map CR CO)

will be held so yes after the

4:57

S… Speaker 4 (260602 Heat Map CR CO)

opening cr

5:00

S… Speaker 1 (260602 Heat Map CR CO)

and conducting an impact assessment after the DCRB

5:04

S… Speaker 1 (260602 Heat Map CR CO)

review, we can make a

5:08

S… Speaker 1 (260602 Heat Map CR CO)

conclusion of timing of implementing

5:12

S… Speaker 1 (260602 Heat Map CR CO)

these changes.

5:14

S… Speaker 1 (260602 Heat Map CR CO)

For example,

5:16

S… Speaker 1 (260602 Heat Map CR CO)

we can cover in initial submission or some deficiency rounds

5:20

S… Speaker 1 (260602 Heat Map CR CO)

or make it change notary or

5:25

S… Speaker 1 (260602 Heat Map CR CO)

on market change like that.

5:28

S… Speaker 1 (260602 Heat Map CR CO)

So that's the only new things

5:32

S… Speaker 1 (260602 Heat Map CR CO)

that rose up in those two

5:36

S… Speaker 1 (260602 Heat Map CR CO)

weeks, I think.

5:37

S… Speaker 2 (260602 Heat Map CR CO)

Yes.

5:38

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

5:40

S… Speaker 3 (260602 Heat Map CR CO)

And these changes have already happened

5:44

S… Speaker 3 (260602 Heat Map CR CO)

from the supplier,

5:47

S… Speaker 5 (260602 Heat Map CR CO)

right?

5:47

S… Speaker 3 (260602 Heat Map CR CO)

So they have already made these changes?

5:50

S… Speaker 5 (260602 Heat Map CR CO)

No,

5:51

S… Speaker 1 (260602 Heat Map CR CO)

they will have made changes.

5:54

S… Speaker 1 (260602 Heat Map CR CO)

So it has not happened yet.

5:59

S… Speaker 1 (260602 Heat Map CR CO)

Okay.

5:59

S… Speaker 3 (260602 Heat Map CR CO)

And do you know when they want to make these changes?

6:02

S… Speaker 5 (260602 Heat Map CR CO)

Oh,

6:03

S… Speaker 1 (260602 Heat Map CR CO)

I'm not really sure,

6:05

S… Speaker 1 (260602 Heat Map CR CO)

but maybe if...

6:11

S… Speaker 1 (260602 Heat Map CR CO)

I'm not really sure.

6:12

S… Speaker 1 (260602 Heat Map CR CO)

I have to check about that.

6:13

S… Speaker 1 (260602 Heat Map CR CO)

That's okay.

6:14

S… Speaker 2 (260602 Heat Map CR CO)

No,

6:14

S… Speaker 1 (260602 Heat Map CR CO)

that's okay.

6:15

S… Speaker 3 (260602 Heat Map CR CO)

That's fine.

6:15

S… Speaker 3 (260602 Heat Map CR CO)

That's no problem.

6:16

S… Speaker 3 (260602 Heat Map CR CO)

Okay.

6:18

S… Speaker 3 (260602 Heat Map CR CO)

So the step we are is we are waiting for this to be

6:22

S… Speaker 3 (260602 Heat Map CR CO)

brought to the DCRB meeting and then this

6:27

S… Speaker 5 (260602 Heat Map CR CO)

could be discussed.

6:28

S… Speaker 5 (260602 Heat Map CR CO)

Okay.

6:30

S… Speaker 1 (260602 Heat Map CR CO)

Yes, so I have added these medics

6:35

S… Speaker 1 (260602 Heat Map CR CO)

regarding,

6:36

S… Speaker 1 (260602 Heat Map CR CO)

regarding medics change added to these two

6:40

S… Speaker 1 (260602 Heat Map CR CO)

RSV and ultradina product as

6:44

S… Speaker 1 (260602 Heat Map CR CO)

to be determined.

6:45

S… Speaker 1 (260602 Heat Map CR CO)

So that's all.

6:48

S… Speaker 1 (260602 Heat Map CR CO)

So that's all.

6:49

S… Speaker 5 (260602 Heat Map CR CO)

Okay.

6:50

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

6:51

S… Speaker 3 (260602 Heat Map CR CO)

And in relation to timelines,

6:53

S… Speaker 3 (260602 Heat Map CR CO)

because I see

6:58

S… Speaker 3 (260602 Heat Map CR CO)

that this is going to affect these two products and potentially

7:03

S… Speaker 3 (260602 Heat Map CR CO)

initial submission.

7:05

S… Speaker 3 (260602 Heat Map CR CO)

We have submitted this already,

7:06

S… Speaker 1 (260602 Heat Map CR CO)

right? So yes,

7:07

S… Speaker 1 (260602 Heat Map CR CO)

RSV we have already submitted and Rotarydino

7:12

S… Speaker 1 (260602 Heat Map CR CO)

we are not.

7:13

S… Speaker 1 (260602 Heat Map CR CO)

We didn't have submitted initially yet,

7:17

S… Speaker 1 (260602 Heat Map CR CO)

so that is planned July 31st,

7:21

S… Speaker 1 (260602 Heat Map CR CO)

so next month.

7:22

S… Speaker 1 (260602 Heat Map CR CO)

So I think we cannot have this

7:26

S… Speaker 1 (260602 Heat Map CR CO)

change into initial submission for Rotarino

7:31

S… Speaker 1 (260602 Heat Map CR CO)

also.

7:31

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

7:37

S… Speaker 1 (260602 Heat Map CR CO)

But maybe we can change on deficiency round,

7:41

S… Speaker 1 (260602 Heat Map CR CO)

but it has to be determined through the review with

7:46

S… Speaker 1 (260602 Heat Map CR CO)

SME.

7:46

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

7:48

S… Speaker 3 (260602 Heat Map CR CO)

So all these CRs,

7:52

S… Speaker 3 (260602 Heat Map CR CO)

anything that it might impact,

7:54

S… Speaker 3 (260602 Heat Map CR CO)

it will potentially be submitted through deficiency rounds,

7:58

S… Speaker 5 (260602 Heat Map CR CO)

right?

7:59

S… Speaker 5 (260602 Heat Map CR CO)

Okay.

8:01

S… Speaker 5 (260602 Heat Map CR CO)

Well,

8:01

S… Speaker 4 (260602 Heat Map CR CO)

I think we do need a discussion on the RCB because,

8:05

S… Speaker 4 (260602 Heat Map CR CO)

you know,

8:06

S… Speaker 4 (260602 Heat Map CR CO)

ideally we'd have all of the CRs through before the

8:10

S… Speaker 4 (260602 Heat Map CR CO)

submission date.

8:11

S… Speaker 4 (260602 Heat Map CR CO)

I'm not totally

8:15

S… Speaker 4 (260602 Heat Map CR CO)

okay with fixing all of these things as part of the efficiency rounds.

8:19

S… Speaker 4 (260602 Heat Map CR CO)

But again,

8:22

S… Speaker 4 (260602 Heat Map CR CO)

that's a decision for the meeting.

8:24

S… Speaker 5 (260602 Heat Map CR CO)

Yes.

8:25

S… Speaker 1 (260602 Heat Map CR CO)

That's for...

8:28

S… Speaker 1 (260602 Heat Map CR CO)

That's for...

8:31

S… Speaker 1 (260602 Heat Map CR CO)

review on the SMS on the DCRB meeting.

8:35

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

8:37

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

8:38

S… Speaker 3 (260602 Heat Map CR CO)

So basically for submission,

8:40

S… Speaker 3 (260602 Heat Map CR CO)

we only have the RSV,

8:42

S… Speaker 3 (260602 Heat Map CR CO)

Chagas and Rotadino,

8:43

S… Speaker 3 (260602 Heat Map CR CO)

and then this new change is going to affect those

8:48

S… Speaker 3 (260602 Heat Map CR CO)

products there?

8:50

S… Speaker 6 (260602 Heat Map CR CO)

Yes.

8:50

S… Speaker 3 (260602 Heat Map CR CO)

Rotadino and RSV?

8:52

S… Speaker 6 (260602 Heat Map CR CO)

Yes.

8:52

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

8:53

S… Speaker 2 (260602 Heat Map CR CO)

Okay.

8:55

S… Speaker 3 (260602 Heat Map CR CO)

So we still need to wait for the DCRB

9:00

S… Speaker 5 (260602 Heat Map CR CO)

discussion,

9:00

S… Speaker 1 (260602 Heat Map CR CO)

right?

9:02

S… Speaker 5 (260602 Heat Map CR CO)

Yes.

9:03

S… Speaker 3 (260602 Heat Map CR CO)

In relation to timelines,

9:05

S… Speaker 2 (260602 Heat Map CR CO)

I see

9:09

S… Speaker 3 (260602 Heat Map CR CO)

that this change is going to affect and it's

9:14

S… Speaker 3 (260602 Heat Map CR CO)

a biological change and everything.

9:15

S… Speaker 3 (260602 Heat Map CR CO)

This is going to be probably significant

9:20

S… Speaker 2 (260602 Heat Map CR CO)

change.

9:21

S… Speaker 3 (260602 Heat Map CR CO)

This is going to affect and get involvement of all the SMEs.

9:26

S… Speaker 3 (260602 Heat Map CR CO)

We need to make sure that we are counting that potential delay in timelines

9:30

S… Speaker 3 (260602 Heat Map CR CO)

if you're planning to submit.

9:33

S… Speaker 2 (260602 Heat Map CR CO)

Also,

9:35

S… Speaker 3 (260602 Heat Map CR CO)

you said that this is the plan change from Medix

9:39

S… Speaker 3 (260602 Heat Map CR CO)

manufacturing.

9:40

S… Speaker 3 (260602 Heat Map CR CO)

It's not done yet.

9:42

S… Speaker 3 (260602 Heat Map CR CO)

They have not complete that change yet,

9:45

S… Speaker 5 (260602 Heat Map CR CO)

right?

9:46

S… Speaker 5 (260602 Heat Map CR CO)

Yes,

9:47

S… Speaker 1 (260602 Heat Map CR CO)

you're right.

9:48

S… Speaker 3 (260602 Heat Map CR CO)

We cannot change before they do.

9:53

S… Speaker 1 (260602 Heat Map CR CO)

So yes,

9:54

S… Speaker 1 (260602 Heat Map CR CO)

you're right.

9:54

S… Speaker 1 (260602 Heat Map CR CO)

We have to wait until they have a real change

9:58

S… Speaker 1 (260602 Heat Map CR CO)

occurs.

10:00

S… Speaker 5 (260602 Heat Map CR CO)

So after that,

10:01

S… Speaker 5 (260602 Heat Map CR CO)

we can move on,

10:03

S… Speaker 1 (260602 Heat Map CR CO)

I think.

10:03

S… Speaker 5 (260602 Heat Map CR CO)

And for RSV,

10:06

S… Speaker 5 (260602 Heat Map CR CO)

we already submitted for the deficiency round

10:11

S… Speaker 5 (260602 Heat Map CR CO)

one.

10:11

S… Speaker 5 (260602 Heat Map CR CO)

So I think it's just an assumption,

10:15

S… Speaker 5 (260602 Heat Map CR CO)

but the medic site transfer should be implemented

10:22

S… Speaker 5 (260602 Heat Map CR CO)

on market.

10:23

S… Speaker 2 (260602 Heat Map CR CO)

So we have no much time

10:27

S… Speaker 5 (260602 Heat Map CR CO)

for RSV.

10:29

S… Speaker 6 (260602 Heat Map CR CO)

Kai,

10:30

S… Speaker 3 (260602 Heat Map CR CO)

could you share the high -level timeline

10:34

S… Speaker 6 (260602 Heat Map CR CO)

on the screen?

10:35

S… Speaker 2 (260602 Heat Map CR CO)

Yes,

10:36

S… Speaker 2 (260602 Heat Map CR CO)

of course.

10:37

S… Speaker 2 (260602 Heat Map CR CO)

That's

10:41

S… Speaker 2 (260602 Heat Map CR CO)

this.

10:43

S… Speaker 2 (260602 Heat Map CR CO)

To my understanding

10:47

S… Speaker 3 (260602 Heat Map CR CO)

from the communication so far,

10:50

S… Speaker 3 (260602 Heat Map CR CO)

it seems like the medics is...

10:54

S… Speaker 3 (260602 Heat Map CR CO)

they will be able to provide us the materials by end

10:58

S… Speaker 2 (260602 Heat Map CR CO)

of this year,

10:59

S… Speaker 3 (260602 Heat Map CR CO)

like around Q4.

11:01

S… Speaker 6 (260602 Heat Map CR CO)

Okay.

11:01

S… Speaker 3 (260602 Heat Map CR CO)

We need to conduct a few tests using these

11:05

S… Speaker 3 (260602 Heat Map CR CO)

materials.

11:06

S… Speaker 3 (260602 Heat Map CR CO)

We

11:10

S… Speaker 3 (260602 Heat Map CR CO)

don't know how long it will take yet.

11:13

S… Speaker 3 (260602 Heat Map CR CO)

Regarding this,

11:15

S… Speaker 3 (260602 Heat Map CR CO)

we're thinking it just looks impossible

11:19

S… Speaker 3 (260602 Heat Map CR CO)

to delay the DR2 timeline until then.

11:23

S… Speaker 3 (260602 Heat Map CR CO)

yes it's probably on market change okay no

11:28

S… Speaker 1 (260602 Heat Map CR CO)

yeah if it's by the end of the year probably yeah okay

11:33

S… Speaker 2 (260602 Heat Map CR CO)

no that's good to know yes so

11:38

S… Speaker 3 (260602 Heat Map CR CO)

that's all in terms of business like

11:42

S… Speaker 3 (260602 Heat Map CR CO)

the stock out is situation is a bit better than

11:47

S… Speaker 6 (260602 Heat Map CR CO)

What was that,

11:48

S… Speaker 3 (260602 Heat Map CR CO)

the Rotadino Biologics case?

11:52

S… Speaker 3 (260602 Heat Map CR CO)

There was another change.

11:53

S… Speaker 3 (260602 Heat Map CR CO)

This one,

11:54

S… Speaker 3 (260602 Heat Map CR CO)

I think they can provide materials until end

11:59

S… Speaker 3 (260602 Heat Map CR CO)

of 27,

12:01

S… Speaker 3 (260602 Heat Map CR CO)

is it correct?

12:02

S… Speaker 2 (260602 Heat Map CR CO)

I'm not really sure about that.

12:06

S… Speaker 2 (260602 Heat Map CR CO)

I have to check.

12:08

S… Speaker 4 (260602 Heat Map CR CO)

It

12:13

S… Speaker 3 (260602 Heat Map CR CO)

will have some impact.

12:14

S… Speaker 3 (260602 Heat Map CR CO)

We need to still assess.

12:17

S… Speaker 3 (260602 Heat Map CR CO)

the length of country registration

12:22

S… Speaker 3 (260602 Heat Map CR CO)

and how much revenue will be

12:26

S… Speaker 3 (260602 Heat Map CR CO)

impacted by the on -market change.

12:28

S… Speaker 3 (260602 Heat Map CR CO)

But to my understanding,

12:32

S… Speaker 3 (260602 Heat Map CR CO)

they can provide the semi -finished goods

12:36

S… Speaker 3 (260602 Heat Map CR CO)

up to 29,

12:40

S… Speaker 3 (260602 Heat Map CR CO)

if I remember correctly.

12:41

S… Speaker 3 (260602 Heat Map CR CO)

So we'll get back to you with better.

12:47

S… Speaker 3 (260602 Heat Map CR CO)

resolution of this information next time or soon.

12:52

S… Speaker 1 (260602 Heat Map CR CO)

That's no problem,

12:53

S… Speaker 1 (260602 Heat Map CR CO)

Ellie. I think it's good to just to know that this is coming,

12:56

S… Speaker 1 (260602 Heat Map CR CO)

but as you mentioned there,

12:58

S… Speaker 1 (260602 Heat Map CR CO)

I don't think it's going to,

13:00

S… Speaker 1 (260602 Heat Map CR CO)

it's most likely going to be a market change because

13:04

S… Speaker 1 (260602 Heat Map CR CO)

the third party manufacturer has

13:08

S… Speaker 1 (260602 Heat Map CR CO)

not implemented and we still have to do our tests,

13:12

S… Speaker 1 (260602 Heat Map CR CO)

right?

13:12

S… Speaker 4 (260602 Heat Map CR CO)

So, all right,

13:15

S… Speaker 1 (260602 Heat Map CR CO)

okay.

13:17

S… Speaker 1 (260602 Heat Map CR CO)

And I know that we said Chlamydia we're parking,

13:20

S… Speaker 1 (260602 Heat Map CR CO)

but still in this under discussion,

13:22

S… Speaker 1 (260602 Heat Map CR CO)

right?

13:22

S… Speaker 2 (260602 Heat Map CR CO)

Yes.

13:23

S… Speaker 1 (260602 Heat Map CR CO)

If it's going to go ahead or not.

13:25

S… Speaker 1 (260602 Heat Map CR CO)

Okay.

13:25

S… Speaker 4 (260602 Heat Map CR CO)

Okay.

13:27

S… Speaker 4 (260602 Heat Map CR CO)

Okay.

13:28

S… Speaker 1 (260602 Heat Map CR CO)

I have nothing else on my side.

13:31

S… Speaker 2 (260602 Heat Map CR CO)

So anyone else?

13:34

S… Speaker 5 (260602 Heat Map CR CO)

Nothing from me.

13:36

S… Speaker 4 (260602 Heat Map CR CO)

No,

13:38

S… Speaker 6 (260602 Heat Map CR CO)

fine from my side.

13:39

S… Speaker 6 (260602 Heat Map CR CO)

Thank you.

13:40

S… Speaker 3 (260602 Heat Map CR CO)

I just want to confirm with change team.

13:44

S… Speaker 3 (260602 Heat Map CR CO)

So now we are holding any additional changes regarding these three products,

13:49

S… Speaker 1 (260602 Heat Map CR CO)

right?

13:52

S… Speaker 1 (260602 Heat Map CR CO)

What do you mean?

13:52

S… Speaker 1 (260602 Heat Map CR CO)

Change freeze?

13:54

S… Speaker 4 (260602 Heat Map CR CO)

Yes,

13:56

S… Speaker 3 (260602 Heat Map CR CO)

because we collected

14:03

S… Speaker 3 (260602 Heat Map CR CO)

changes to heat map analysis.

14:06

S… Speaker 3 (260602 Heat Map CR CO)

From that point on,

14:08

S… Speaker 3 (260602 Heat Map CR CO)

we probably need to hold additional changes.

14:11

S… Speaker 4 (260602 Heat Map CR CO)

The

14:16

S… Speaker 1 (260602 Heat Map CR CO)

way it happens,

14:17

S… Speaker 1 (260602 Heat Map CR CO)

and this is also for implementation and on CE,

14:20

S… Speaker 1 (260602 Heat Map CR CO)

if we see any change coming in.

14:25

S… Speaker 1 (260602 Heat Map CR CO)

That change we need should be escalated to the PMs and to see impact

14:30

S… Speaker 1 (260602 Heat Map CR CO)

and everything and talk through as a CFD.

14:34

S… Speaker 1 (260602 Heat Map CR CO)

Depending on the change,

14:36

S… Speaker 1 (260602 Heat Map CR CO)

they can't hold.

14:38

S… Speaker 1 (260602 Heat Map CR CO)

But most some of the changes,

14:41

S… Speaker 1 (260602 Heat Map CR CO)

yes,

14:42

S… Speaker 1 (260602 Heat Map CR CO)

they can hold.

14:43

S… Speaker 1 (260602 Heat Map CR CO)

So it's a discussion.

14:44

S… Speaker 1 (260602 Heat Map CR CO)

We asked for a change freeze so many times,

14:48

S… Speaker 1 (260602 Heat Map CR CO)

Ellie, but that doesn't really happen.

14:53

S… Speaker 3 (260602 Heat Map CR CO)

Yeah, I mean,

14:54

S… Speaker 3 (260602 Heat Map CR CO)

once in a while I participate in the DCRB

14:58

S… Speaker 3 (260602 Heat Map CR CO)

meeting, some changes are just not

15:03

S… Speaker 3 (260602 Heat Map CR CO)

very clear if it has impact on these products or not.

15:07

S… Speaker 4 (260602 Heat Map CR CO)

So

15:11

S… Speaker 1 (260602 Heat Map CR CO)

if there is an impact,

15:13

S… Speaker 1 (260602 Heat Map CR CO)

and that's the best form as well for you to know,

15:16

S… Speaker 1 (260602 Heat Map CR CO)

like it's the DCRB.

15:18

S… Speaker 1 (260602 Heat Map CR CO)

The change team will do the best to highlight anything

15:23

S… Speaker 1 (260602 Heat Map CR CO)

that might be coming towards and for the discussion we need to be held.

15:27

S… Speaker 1 (260602 Heat Map CR CO)

But that's where we are.

15:29

S… Speaker 1 (260602 Heat Map CR CO)

We asked for a change freeze,

15:31

S… Speaker 1 (260602 Heat Map CR CO)

but the business already said that it's not possible depending on which one it is.

15:35

S… Speaker 1 (260602 Heat Map CR CO)

But there are discussions where

15:40

S… Speaker 1 (260602 Heat Map CR CO)

potentially the change could make into not the submission,

15:44

S… Speaker 1 (260602 Heat Map CR CO)

but the implementation or on market and so

15:48

S… Speaker 1 (260602 Heat Map CR CO)

on and so on.

15:49

S… Speaker 1 (260602 Heat Map CR CO)

That's the type of discussion that needs to be held when the CR is

15:53

S… Speaker 1 (260602 Heat Map CR CO)

submitted through the CRB.

15:56

S… Speaker 4 (260602 Heat Map CR CO)

Yeah,

15:58

S… Speaker 3 (260602 Heat Map CR CO)

I'm a bit worried since we talked about business,

16:02

S… Speaker 2 (260602 Heat Map CR CO)

because these products there.

16:07

S… Speaker 3 (260602 Heat Map CR CO)

Some of them,

16:08

S… Speaker 3 (260602 Heat Map CR CO)

the country registration timeline is quite tight

16:13

S… Speaker 3 (260602 Heat Map CR CO)

with the cutoff.

16:15

S… Speaker 3 (260602 Heat Map CR CO)

If any change in notification needs

16:19

S… Speaker 3 (260602 Heat Map CR CO)

to happen, this is a risk.

16:23

S… Speaker 3 (260602 Heat Map CR CO)

I agree with

16:27

S… Speaker 1 (260602 Heat Map CR CO)

you. I know that there was an email sent.

16:32

S… Speaker 1 (260602 Heat Map CR CO)

for change freeze at the beginning of the year,

16:34

S… Speaker 1 (260602 Heat Map CR CO)

but the change is still continuous to be created.

16:37

S… Speaker 1 (260602 Heat Map CR CO)

So if there is a change freeze,

16:41

S… Speaker 1 (260602 Heat Map CR CO)

it needs to be coming from upper management,

16:43

S… Speaker 1 (260602 Heat Map CR CO)

not change team.

16:45

S… Speaker 1 (260602 Heat Map CR CO)

Change team is like,

16:47

S… Speaker 1 (260602 Heat Map CR CO)

we don't have that power,

16:49

S… Speaker 1 (260602 Heat Map CR CO)

Ellie.

16:49

S… Speaker 1 (260602 Heat Map CR CO)

I wish I had.

16:50

S… Speaker 4 (260602 Heat Map CR CO)

Okay,

16:53

S… Speaker 3 (260602 Heat Map CR CO)

so constant cooperation.

16:55

S… Speaker 2 (260602 Heat Map CR CO)

Yes,

16:56

S… Speaker 1 (260602 Heat Map CR CO)

unfortunately.

16:59

S… Speaker 1 (260602 Heat Map CR CO)

That's the best way we can do as a team.

17:02

S… Speaker 1 (260602 Heat Map CR CO)

PMs and the change team is bring awareness

17:06

S… Speaker 1 (260602 Heat Map CR CO)

to everyone.

17:07

S… Speaker 4 (260602 Heat Map CR CO)

Thank you.

17:10

S… Speaker 2 (260602 Heat Map CR CO)

No worries.

17:12

S… Speaker 4 (260602 Heat Map CR CO)

Anything

17:17

S… Speaker 1 (260602 Heat Map CR CO)

else?

17:18

S… Speaker 4 (260602 Heat Map CR CO)

It seems fine.

17:22

S… Speaker 4 (260602 Heat Map CR CO)

Yes,

17:25

S… Speaker 5 (260602 Heat Map CR CO)

it seems fine.

17:26

S… Speaker 2 (260602 Heat Map CR CO)

That's perfect.

17:29

S… Speaker 1 (260602 Heat Map CR CO)

Thank you very much.

17:31

S… Speaker 2 (260602 Heat Map CR CO)

Thank you for your time.

17:32

S… Speaker 2 (260602 Heat Map CR CO)

Thank you.

17:34

S… Speaker 2 (260602 Heat Map CR CO)

Have a good day.

17:35

S… Speaker 2 (260602 Heat Map CR CO)

Bye -bye.

260602 Heat Map CR CO

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