M. Pharm (Drug Regulatory Affairs)

Program Code 10519

Campus Noida

Institute Amity Institute of Pharmacy

University Amity University Uttar Pradesh

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

Duration 2 Years

Selection Process English Language TestSubject Based ...

  • Program Fee (Rs. in Lacs)
  • 1st Year Non Sponsored Semester 0.58
  • 1st Year Sponsored Semester Fee 0.87

Course Structure

1st Year

Semester 1

  • Seminar - I [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

  • Assignment [Non Teaching Credit Courses]
  • Regulatory Aspects of Medical Devices [Core Courses]
  • Regulatory Affairs Practical II [Core Courses]
  • Regulatory Aspects of Drugs & Cosmetics [Core Courses]
  • Regulatory Aspects of Food & Nutraceuticals [Core Courses]
  • Regulatory Aspects of Herbal & Biologicals [Core Courses]
  • Communication for Employment [Communication Skills]
  • Conflict Resolution and Management [Behavioural Science]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses

2nd Year

Semester 3

  • Journal Club - I [Non Teaching Credit Courses]
  • Proposal Presentation [Non Teaching Credit Courses]
  • Research Work - I [Non Teaching Credit Courses]
  • Research Methodology and Biostatistics- [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

  • Discussion/ Final Presesntation [Non Teaching Credit Courses]
  • Journal Club - II [Non Teaching Credit Courses]
  • Research Work - II [Non Teaching Credit Courses]
  • Foreign Business Language
  • Open Elective Courses
  • Outdoor Activity Based Courses