Download PTU M-Pharma 2019 May 1st Semester 74660 REGULATORY AFFAIRS Question Paper

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Total No. of Pages : 01

Total No. of Questions : 06

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

REGULATORY AFFAIRS

Subject Code : MPH-104T

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M.Code: 74660

Time: 3 Hrs.

Max. Marks: 75

INSTRUCTIONS TO CANDIDATES :

1. Attempt any FIVE questions out of SIX questions.

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2. Each question carries FIFTEEN marks.

1. Discuss the following with suitable examples and/or flow charts :

   1. ECTD (5)
   2. Scale-up process approval (5)
   3. Regulation for combination products (5)

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2. Discuss the NDA regulatory approval process with suitable example. (8+7)

3. Write short notes on the following :

   1. Drug product performance (5)

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   2. Master formula record (5)
   3. Post marketing surveillance (5)

4. Give a detailed account on development of clinical trial protocol for an anti- depressant drug. (15)

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5. Write short notes on the following :

   1. ICH-S guidelines (8)
   2. Regulatory requirements of MHRA (7)

6. Discuss the following with suitable examples :

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   1. IND (5)
   2. Dossier (IMPD) (5)
   3. HIPAA (5)

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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