M. Pharm (Drug Regulatory Affairs)

Post Graduate Programmes

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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.

  • Duration
  • 2 years
  • 1st Year Non Sponsored Semester Fee (Rs. in Lacs)
  • 0.61
  • 1st Year Sponsored Semester Fee (Rs. in Lacs)
  • 0.915
 
  • Fee Structure
  • Program Educational Objectives
  • Program Learning Outcomes
1st Year Non Sponsored Semester Fee (Rs. in Lacs) : 0.61
1st Year Sponsored Semester Fee (Rs. in Lacs) : 0.915
  • Students will be able to demonstrate knowledge of the applications of Pharmacological Screening methods
  • Students will be able to develop and sustain effective individual and organizational performance by leveraging Research skills, Information and Technological competencies in the given Pharmaceutical framework
  • Students will be able to understand the use of modern day equipments for various animals models studies.
  • Students will be able to demonstrate effective communication skills that support and enhance effectiveness in Pharmacy Practice and Pharmaceutical Industry.
  • Students will be able to develop positive perspectives and skills that create productive domain leaders and improved health outcomes globally.
  • Students will be able to act ethically and responsibly
  • Students will be able to critically evaluate and reflect learning and development throughout their career.
  • Students will be able to utilize theory and practice, and expertise across functional areas in Pharmaceutical Sciences making effective decisions by understanding the relationship of Pharmaceutical Sciences activities to global environment
  • 1 1. Students will demonstrate knowledge of the application of Health and Allied Sciences areas principles and practices in a professional work setting 2. Students will develop and sustain effective individual and organizational performance by leveraging Research skills, Information and Technological competencies in the given Health and Allied Sciences areas framework 3. Students will appropriately apply compassion and influential skills in working with patients, attendants, colleagues and the community. 4. Students will demonstrate effective communication skills that support and enhance effectiveness in Health and Allied Sciences areas. 5. Students will develop positive perspectives and skills that create productive domain leaders and improved health outcomes globally. 6. Students will act ethically and responsibly 7. Students will critically evaluate and reflect learning and development throughout their career 8. Students will utilize theory and practice, and expertise across functiona
  • Creativity, Innovation & reflective thinking
  • Self-Directed and Active Learning
  • Analytical & Decision Making Ability
  • Cultural Intelligence & Diversity Multicultural Understanding & Global Outlook
  • Pharmaceutical Sciences Knowledge and Expertise
  • Research literacy and proficiency in Pharmaceutical Sciences
  • Information & Digital Literacy
  • Problem Solving & Decision Making
  • Communication Skills
  • Team work Leadership and Behavioural Skills
  • Global Outlook promoting achievement of improved health outcomes in a National and Global context.
  • Ethical and Professional Conduct
  • Employability Entrepreneurship Skill
  • Lifelong Learning
  • Discipline Knowledge & Expertise
  • Self-Directed and Active Learning
  • Research and Enquiry
  • Information & Communication Technology Skills
  • Critical Thinking & Problem-Solving Abilities
  • Communication Skills
  • Creativity, Innovation & Reflective Thinking
  • Analytical & Decision-Making Ability
  • Leadership & Teamwork
  • Multicultural Understanding & Global Outlook
  • Integrity and Ethics
  • Social & Emotional Skills
  • Employability, Enterprise & Entrepreneurship
  • Lifelong Learning
  • Environment & Sustainability

Course Structure

  • 1st Year
  • 2nd Year

Semester 1

Course Title Course Type Credit L T PS SW Total Credits Syllabus
Clinical Research Regulations (PG) Core Courses 4 0 0 0 4.00 View
Documentation and Regulatory Writing (PG) Core Courses 4 0 0 0 4.00 View
Good Regulatory Practices (PG) Core Courses 4 0 0 0 4.00 View
Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights (PG) Core Courses 4 0 0 0 4.00 View
Regulatory Affairs Practical I (PG) Core Courses 0 0 12 0 6.00 View
Seminar - I (PG) Non Teaching Credit Courses 0 0 0 0 4.00 View

Semester 2

Course Title Course Type Credit L T PS SW Total Credits Syllabus
Regulatory Aspects of Medical Devices (PG) Core Courses 0 0 0 0 0.00 View
Regulatory Affairs Practical II (PG) Core Courses 0 0 0 0 0.00 View
Regulatory Aspects of Drugs & Cosmetics (PG) Core Courses 0 0 0 0 0.00 View
Regulatory Aspects of Food & Nutraceuticals (PG) Core Courses 0 0 0 0 0.00 View
Regulatory Aspects of Herbal & Biologicals (PG) Core Courses 0 0 0 0 0.00 View
ARTIFICIAL INTELLIGENCE FOR HEALTHCARE & PHARMACY (PG) Industry Specific Courses 0 0 0 0 0.00 View
Assignment (PG) Non Teaching Credit Courses 0 0 0 0 4.00 View

Semester 3

Course Title Course Type Credit L T PS SW Total Credits Syllabus
Journal Club - I (PG) Non Teaching Credit Courses 0 0 0 0 1.00 View
Proposal Presentation (PG) Non Teaching Credit Courses 0 0 0 0 2.00 View
Research Work - I (PG) Non Teaching Credit Courses 0 0 0 0 14.00 View
Research Methodology and Biostatistics- (PG) Core Courses 0 0 0 0 0.00 View