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Post Graduate Programmes

M. Pharm (Drug Regulatory Affairs)

Program Code 10519

Course Overview

  • Campus
  • Noida
  • Institute
  • Amity Institute of Pharmacy
  • University
  • Amity University Uttar Pradesh
  • Program Code
  • 10519
  • Eligibility
  • B. Pharm (min 60%) from PCI recognized Institute.

  • Selection Process
  • English Language Test
    Subject Based Written Test
    Personal Interview
  • Duration
  • 2 Years
  • Remark
  • 1st Year Non Sponsored Semester Fee (Rs. in Lacs)
  • 0.525
  • 1st Year Sponsored Semester Fee (Rs. in Lacs)
  • 0.79
  • Fee Structure
  • 1st Year Non Sponsored Semester Fee (Rs. in Lacs) : 0.525
  • 1st Year Sponsored Semester Fee (Rs. in Lacs) : 0.79

Course Structure

  • 1st Year
  • 2nd Year

    Semester 1

  • Seminar [Non Teaching Credit Courses]
  • Clinical Research Regulations [Core Courses]
  • Documentation and Regulatory Writing [Core Courses]
  • Good Regulatory Practices [Core Courses]
  • Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights [Core Courses]
  • Regulatory Affairs Practical I [Core Courses]
  • Advanced Communication [Communication Skills]
  • Self Development and Interpersonal Skills [Behavioural Science]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses

    Semester 2

  • Minor Project [Non Teaching Credit Courses]
  • Ayush in Public Health [Domain Elective Courses]
  • AYUSH: Role of Alternative Medicine in Public Health [Domain Elective Courses]
  • Clinical Trials and Healthcare Policies [Core Courses]
  • Emerging Concept in Regulatory Affairs [Core Courses]
  • Global Regulatory Aspects [Core Courses]
  • International Regulatory Systems [Core Courses]
  • National Regulatory Affairs [Core Courses]
  • Communication for Employment [Communication Skills]
  • Conflict Resolution and Management [Behavioural Science]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses

    Semester 3

  • Fundamentals of Medical and Scientific Writing [Specialisation Elective Courses]
  • Innovation in Pharmaceutical Sciences [Specialisation Elective Courses]
  • Pharmaceutical Production and Management [Specialisation Elective Courses]
  • Summer Internship [Non Teaching Credit Courses]
  • Synopsis [Mandatory Courses]
  • Natural Products and Herbal Medicines [Domain Elective Courses]
  • Nutraceuticals [Domain Elective Courses]
  • Drug Regulatory Affairs Intellectual Property Rights and Bioethics [Core Courses]
  • Pharmaceutical Biostatics and Computer Applications [Core Courses]
  • Professional Communication Skills [Communication Skills]
  • Professional Competencies and Career Development [Behavioural Science]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses

    Semester 4

  • Major Project [Non Teaching Credit Courses]
  • Ayush in Public Health [Domain Elective Courses]
  • Quality Assurance Glp Gmp and Validation [Core Courses]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses

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