Labeling update process

Labeling update process

Professional Development

10 Qs

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Labeling update process

Labeling update process

Assessment

Quiz

Other

Professional Development

Practice Problem

Hard

Created by

Sumi Sebastian

Used 2+ times

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10 questions

Show all answers

1.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

Which of the following is not a locally driven update?

MAH address change

GDS updates

Template change

Local regulatory requirements

2.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

HTG for country labeling support for local submissions

VQD-REF-013248

VQD-REF-013244

VQD-REF-019698

VQD-REF-019699

3.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

We are not providing country label outputs in this language

Arabic

French

German

Spanish

4.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

KPIs are calculated on the basis of

Right first time

Delivery on time

Both

None of these

5.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

Which of the following is not categorized as a major error?

Under section 4.4 the revised statement did not fully follow the text in the reference PI as required

License number incorrect in CL

Provided details of EU approval letter when this information was not required.

The wrong reference PI was provided

6.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

For ectd markets who assigns the task to SPOCs in country labeling

Assembly

LOC

Self assign

None of these

7.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

Which of the following is not a global PI

Global Datasheet

Partner Datasheet

USPI

Non-Central Datasheet

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