FirstRanker Logo

FirstRanker.com - FirstRanker's Choice is a hub of Question Papers & Study Materials for B-Tech, B.E, M-Tech, MCA, M.Sc, MBBS, BDS, MBA, B.Sc, Degree, B.Sc Nursing, B-Pharmacy, D-Pharmacy, MD, Medical, Dental, Engineering students. All services of FirstRanker.com are FREE

📱

Get the MBBS Question Bank Android App

Access previous years' papers, solved question papers, notes, and more on the go!

Install From Play Store

Download RTMNU B.Pharma 5th Semester 2016 Summer Regulatory Affairs and Intellectual Property Right Question Paper

Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 5th Semester 2016 Summer Regulatory Affairs and Intellectual Property Right Question Paper

This post was last modified on 19 January 2020

This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University


TKN/KS/16-6998

FirstRanker.com

First/Second/Third/Fourth/Fifth/Sixth Semester Examination for the Degree of Bachelor of Pharmacy

--- Content provided by FirstRanker.com ---

REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT

5-T-6

Time: Three Hours ] [Max. Marks: 80

N. B. : (1) Question No. 1 is compulsory.

(2) Attempt any four questions from the remaining.

--- Content provided by FirstRanker.com ---

(3) Draw neat labelled diagram wherever necessary.

(4) Discuss the reaction, mechanism wherever necessary.

(5) Use of electronic calculator is permitted.

(6) Assume suitable data wherever necessary.

  1. Solve any five of the following :-
    1. Define patent. Write the various criteria for granting the patent.
    2. --- Content provided by FirstRanker.com ---

    3. What is the role of Medicines and Health Care Regulatory Agency (MHRA).
    4. Explain Hatch - Waxman Act.
    5. Describe the term Intellectual property rights.
    6. Mention the concept and format of an IND application.
    7. Write short note on New drug application.
    8. --- Content provided by FirstRanker.com ---

    9. Describe Role of World Trade Organization (WTO).

    5 x 4 = 20

    1. Describe the various requirements for filing ANDA 7
    2. Discuss in detail the various International treaties and convention on IPR. 8
    3. --- Content provided by FirstRanker.com ---

  2. Explain the procedure for patent filling, searching and licensing. 15
    1. Write in detail on International Conference on Harmonisation (ICH). 7
    2. Why the drug regulatory agencies are necessary ? Explain Therapeutic Goods Administration (TGA). 8
  3. --- Content provided by FirstRanker.com ---

  4. Define patent Act 1970, and patentability criteria and their importance. 15
  5. Write the FDA guidelines, contents for New drug application. 15
  6. Write short notes on (any three) :-
    1. Law related to biosimilars.
    2. General Agreement on Trade and Tariff (GATT).
    3. Indian Pharmacopoeia Commission (IPC).
    4. --- Content provided by FirstRanker.com ---

    5. Medicines and Healthcare Regulatory Agency (MHRA).

    5 x 3 = 15


--- Content provided by FirstRanker.com ---


This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University