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CLPT B.Pharm ACTD Slip test

Total questions: 10

Worksheet time: 6mins

Name
Class
Date
1.

What is ACTD?

a)

ASEAN COMMON TECHNICAL DOSSIER

b)

ASEAN COMMON TECHNICAL DOCUMENT

c)

ASEAN COMMON TECHNOLOGICAL DOSSIER

2.

ACTD Composed of how many parts?

a)

4

b)

5

c)

3

3.

Part 1 ACTD Contains?

a)

Organisation of the Dossier

b)

Quality of Document

c)

Clinical Document

4.

Part 2 ACTD Contains?

a)

Organisation of the Dossier

b)

Quality of Document

c)

Clinical Document

5.

Part 3 ACTD Contains?

a)

Nonclinical Document

b)

Quality of Document

c)

Clinical Document

6.

Part 4 ACTD Contains?

a)

Nonclinical Document

b)

Quality of Document

c)

Clinical Document

7.

What is meant by NCE?

(a)  

8.

This ACTD guideline describes a CTD format that will significantly reduce the (a)   and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions.

9.

how many member states in ASEAN?

a)

10

b)

5

c)

7

10.

Is India part of the ASEAN Member States?

a)

YES

b)

NO