Download PTU M.Pharm 2020 March 1st Sem 74660 Regulatory Affairs Question Paper

Roll No. Total No. of Pages : 01

Total No. of Questions : 06

M.Pharmacy (Pharmaceutics) (2017 & Onwards) (Sem.-1)

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REGULATORY AFFAIRS

Subject Code : MPH-104T

M.Code : 74660 Max. Marks: 75

Time: 3 Hrs.

INSTRUCTIONS TO CANDIDATES :

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1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. Give detailed account on documentation in pharmaceutical industries with suitable examples. 15

2. Write short notes on:

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   1. ANDA 5
   2. NDA 5
   3. Scale up process after approval 5

3. Discuss various aspects of CRO in detail with suitable examples. 15

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4. Briefly discuss the following:

   1. Hatch-Waxman act and amendments 7
   2. Regulatory requirements of EU 8

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5. Write short notes on:

   1. In-vitro product performance 5
   2. Generic drugs 5
   3. IND 5

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6. 1. Write clinical trial protocol for new anti-cancer drug. 9
   2. Elaborate on the role and responsibilities of institutional review boards / independent ethics committee in clinical trials. 6

NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.

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