M. Pharm (Pharmaceutical Regulatory Affairs)

Program Code 101958

Campus Noida

Institute Amity Institute of Pharmacy

University Amity University Uttar Pradesh

Eligibility B Pharm. (agg. 60%) from PCI recognized ...

Duration 2 Years

Selection Process Personal Interview

  • Program Fee (Rs. in Lacs)
  • 1st Year Non Sponsored Semester 0.72
  • 1st Year Sponsored Semester Fee 1.08
Admission Not open

Course Structure

  • 1st Year
  • 2nd Year

Semester – 1

    Core Courses
  • Clinical Research Regulations
  • Good Regulatory Practices
  • Documentation and Regulatory Writing
  • Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights
  • Regulatory Affairs Practical I
    Common Curriculum Courses
  • Professional and Business Communications
  • Foreign Business Language - I (Arabic/Chinese/French/German/Japanese/Russian/Sanskrit/Spanish)
    Non-Teaching Credit Courses
  • Seminar - I

Semester – 2

    Core Courses
  • Regulatory Aspects of Drugs & Cosmetics
  • Regulatory Aspects of Herbal & Biologicals
  • Regulatory Aspects of Medical Devices
  • Regulatory Aspects of Food & Nutraceuticals
  • Regulatory Affairs Practical II
    Industry Specific Courses
  • Artificial Intelligence For Healthcare & Pharmacy
    Common Curriculum Courses
  • Cognitive Analytics & Social Skills for Professional Development
  • Foreign Business Language - II (Arabic/Chinese/French/German/Japanese/Russian/Sanskrit/Spanish)
    Non-Teaching Credit Courses
  • Assignment

Semester – 3

    Core Courses
  • Research Methodology and Biostatistics
    Common Curriculum Courses
  • Foreign Business Language - III (Arabic/Chinese/French/German/Japanese/Russian/Sanskrit/Spanish)
  • Professional Ethics and Social Responsibility
    Non-Teaching Credit Courses
  • Journal Club - I
  • Proposal Presentation
  • Research Work - I

Semester – 4

    Non-Teaching Credit Courses
  • Discussion/ Final Presentation
  • Journal Club - II
  • Research Work - II