Drug regulatory affairs IGNOU

Hello I want the sample paper for the Drug regulatory Affairs exam of IGNOU for the preparation so kindly provide me the details please?????

[Kiran Chandar]

The Indira Gandhi National Open University, also known as IGNOU, it is a distance learning national university located in IGNOU road, Maidan Garhi, New Delhi, India. It was established in the year of 1985.

As you are asking for the sample paper of Drug Regulatory Affairs of IGNOU so here I am providing you the sample paper below.

1. (a) Describe the role of pharmacy council India in pharmacy education. (5)

(b) Write a short note on Indian Pharmaceutical Industry. (5)

2. (a) What are different types of toxicity studies and describe any one type of study in details? (6)

(b) State the limitation of toxicity studies. (4)

3. (a) What are different phases of clinical trial and their importance ? (6)

(b) What is safety criteria for large scale experiments and manufacturing adopted by Genetic engineering approval committee? (4)

4. (a) Outline the procedure for pricing of formulation by NPPA? (6)

(b) What are the functions of Reviews Committee on Genetic Manipulation (RCGM) ? (4)

5. (a) Give an outline of clinical studies in paediatric special population with reference to clinical trials. (6)

(b) Give the full form of the following (any four): (4)

(i) BRCPC (ii) ICMR
(iii) NDA (iv) RCGM
(v) IND (vi) CDSCO
(vii) IDMA

6. Discuss any two : (5x2=10)
(a) The Drugs and Magic Remedies act
(b) Drug Consultative Committee
(c) Spurious drugs

7. Write short notes on (any two) : (5x2=10)
(a) Drugs Technical Advisory Board
(b) Expiry date of Drugs
(c) Single and double blind studies
(d) New Drugs

8. (a) Outline the requirement of labelling of Medicine. (6)

(b) Describe different types of Investigational new drugs. (4)

Contact Details:

Indira Gandhi National Open University
Maidan Garhi Village, Chhatarpur,
New Delhi, Delhi 110062

[MAP]Indira Gandhi National Open University[/MAP]

Hello I want the sample paper for the Drug regulatory Affairs exam of IGNOU for the preparation so kindly provide me the details please?????