GEETHANJALI COLLEGE OF PHARMACY

Cheeryal (V), Keesara (M), Medchal Dist.

B. Pharmacy IV- Year I-Sem, II- Mid Term Exam, DEC-2023
PHARMACOVIGILANCE - OBJECTIVE EXAM
Name: ______________________________ Hall Ticket No.________________
Answer All Questions. All Questions Carry Equal Marks. Time: 20 Min. Marks: 10

I. Choose the correct alternative:

1. What are the minimum criteria required for a valid case? ( )

a An identifiable reporter b order An identifiable patient

c command d All of the above

2. Good pharmacovigilance practice (GVP) guidelines released by ( )

a European Medicines Agency b Indian Medicines agency

c American medicines agency d British Medicines agency

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
3. ( )
guideline

a E2A b E2B(R3)

c E2B(R2) d E2C(R1)

4. D&C act was passed in ( )

a 1947 b 1980

c 1940 d 1941

5. Identify the relevant regulatory body in USFDA for approval of drugs. ( )

a) BLA b CBER

c) IND d CDER

6. Method of PV in pediatrics is mention in which section of ICH guidelines ( )

a) E-2 E-6

c) E-11 E-18

7. _____FDA category drugs are contraindicated in pregnancy ( )

a A b C
 GEETHANJALI COLLEGE OF PHARMACY
Cheeryal (V), Keesara (M), Medchal Dist.
c D d X

According to ICH GCP guidelines, which document outlines the objective(s), design,
8. ( )
methodology, statistical considerations, and organization of a clinical trial?

a Case Report b Clinical Study protocol

c Informed consent form d Investigator Brochure

 GEETHANJALI COLLEGE OF PHARMACY
Cheeryal (V), Keesara (M), Medchal Dist.

9. _________number of principles are there in ICH- Good clinical practice ( )

a) 11 b 12

c) 13 d 14

As per which guidelines tight to make informed consent during clinical trials is made mandatory (
10
)

a Nuremberg code b Declaration of Helsinki

c Belmont report d Kefauver harris amendment

II. Fill in the Blanks

 GEETHANJALI COLLEGE OF PHARMACY
Cheeryal (V), Keesara (M), Medchal Dist.

11. Indian Pharmacopoeia Commission headquarter is located at

12. The term of patent is valid for the period of 20 years from the _______________________

13. The guidelines for good manufacturing practice in India is________________________________

14. Targeted clinical investigations requires________________________ approval

15. Indian Pharmacovigilance system is regulated by___________

16. The ICH E2 guidelines specify about________________________________

17. _____________is a schedule in the Drugs and Cosmetics Act of India that provides guidelines

for the conduct of clinical trials of new drugs in India.

18. In general, expedited reporting of serious and unexpected ADRs is required as soon as possible,

but in no case later than ______________ calendar days

19. Expand FAERS________________________________________________________

20. Name the regulatory authority of UK _________________________________

 GEETHANJALI COLLEGE OF PHARMACY
Cheeryal (V), Keesara (M), Medchal Dist.

KEYS

1.D

2.A

3.A

4. C

5.D

6.C

7.D

8.B

9. C

10. B

11.Ghaziabad

12. Date of filing of appilications

13. Schedule M

14.IEC/IRB

15. CDSCO

16. Pharmacovigilance methods

17.Schedule Y

18.15

19. FDA Adverse Event Reporting System

20. MHRA The Medicines and Healthcare products Regulatory Agency

PREPARED BY: CHECKED BY: PRINCIPAL

SEC A:

SEC B: