M. Pharmacy in Pharmaceutical Regulatory Affairs

The M. Pharmacy in Pharmaceutical Regulatory Affairs is a specialized postgraduate program designed to equip students with in-depth knowledge and skills required to navigate the complex regulatory frameworks governing the pharmaceutical industry. This program focuses on the legal, scientific, and ethical aspects of pharmaceutical regulation, including drug development, clinical trials, manufacturing standards, and compliance with national and international guidelines.

Why Choose M. Pharm in Pharmaceutical Regulatory Affairs?

The M. Pharm in Pharmaceutical Regulatory Affairs is an ideal choice for students who aspire to specialize in the highly dynamic and crucial area of pharmaceutical regulations. This program provides an in-depth understanding of the regulatory environment governing the pharmaceutical and healthcare sectors, making it a perfect fit for those interested in ensuring that pharmaceutical products comply with safety, quality, and efficacy standards. Here are some key reasons why you should choose this program:

Advantages

  • Diverse Career Options: Graduates can pursue a wide range of roles within pharmaceutical companies, regulatory agencies, and healthcare organizations. The program prepares you to take on leadership positions in regulatory affairs, compliance, and quality assurance.
  • Exposure to Cutting-Edge Industry Trends: Regulatory affairs professionals are at the forefront of drug development, clinical trials, and the implementation of new drug approval processes. Students have the opportunity to work with the latest technologies and industry trends, which opens up pathways for innovation.
  • Job Stability and Growth: As the pharmaceutical industry continues to grow and evolve, regulatory affairs professionals are in high demand. The role of regulatory affairs is indispensable, ensuring job security and career stability.
  • Interdisciplinary Learning: This program blends various disciplines such as pharmaceutical sciences, law, ethics, and public health, providing you with a well-rounded education. The program also offers practical exposure to regulatory submissions and compliance procedures.
  • Global Recognition: Pharmaceutical Regulatory Affairs is a globally recognized field, and professionals with specialized training can find job opportunities not only in their home country but also internationally. This gives graduates the chance to work with global pharmaceutical organizations and regulatory bodies.

Career Opportunities in the Core Sector (Pharmaceutical Industry)

  1. Regulatory Affairs Manager/Director
  2. Regulatory Affairs Associate/Officer
  3. Clinical Research Associate
  4. Pharmacovigilance Officer
  5. Regulatory Consultant
  6. Quality Assurance/Control Specialist
  7. Government and Regulatory Agency Roles
  8. Research and Development (R&D) Specialist
  9. Regulatory Affairs Trainer
  10. Regulatory Compliance Officer
  11. Clinical Trials Regulatory Affairs Specialist
  12. Regulatory Affairs Liaison Officer

Career Opportunities in the Corporate Sector (Non-Pharmaceutical Companies)

  1. Regulatory Affairs Consultant
  2. Corporate Regulatory Affairs Specialist
  3. Regulatory Affairs Trainer or Educator
  4. Regulatory Affairs Program Manager
  5. Regulatory Affairs in Health Insurance Companies
  6. Legal and Compliance Roles in Pharmaceutical Law Firms:
  7. Regulatory Affairs Policy Analyst
  8. Corporate Strategy or Risk Management Consultant
  9. Medical Device Regulatory Affairs Specialist

ACADEMIC REGULATIONS FOR M. Pharm

To be eligible for the award of the M. Pharm. degree, a student must:

  1. Complete the course in a minimum of two years and a maximum of four years.
  2. Register for and earn 95 credits.
  3. If a student does not meet all academic requirements within four years of admission, they will lose their seat, and their admission will be cancelled.

Eligibility for admission to the M. Pharm. program is based on the following:

  1. The eligibility, qualifications, and specialization requirements set by the A.P. State Government/University, which may change over time.
  2. Admissions are determined by the merit rank or percentile obtained in the relevant GPAT Exam, or through a merit rank in the APPGECET entrance test (conducted by the A.P. State Government), a university entrance test, or any other approved examination, with reservations as specified by the government.

Programme Pattern:

  1. The total duration is two academic years.
  2. Each year is divided into two semesters.
  3. Each semester lasts 22 weeks, including exams, with at least 90 instructional days.
  4. Students must complete all academic requirements within four years from the start of the first semester; otherwise, they will forfeit their seat in the program.

Attendance Requirements:

  1. A student must have at least 50% attendance in each course and 75% overall attendance across all courses to be eligible for the University external exams.
  2. The College Academic Committee may grant a condonation for attendance shortages of up to 10% (between 65% and 75%) in each semester.
  3. Condonation will only be granted for genuine reasons, supported by appropriate evidence submitted by the student.

The evaluation process for the M. Pharm. program is as follows:

  1. Theory Subjects: Each theory subject is evaluated for a total of 100 marks, with 60 marks for the End Semester Examination and 40 marks for Internal Evaluation.
  • Two internal exams are conducted (30 marks each). The first covers Units I & II, and the second covers Units III, IV, and V. Each internal exam lasts 120 minutes with 3 questions (10 marks each).
  • The final internal marks (30) are calculated by giving 80% weight to the better internal exam and 20% to the other.
  • There is also an online exam (20 objective questions) for the remaining 10 marks.
    1. Practical Subjects: Practical exams are evaluated for 100 marks, with 60 marks for the End Semester Examination and 40 marks for internal evaluation based on day-to-day performance.
    2. Seminar/Assignment: There is an internal evaluation worth 100 marks. A minimum of 50% marks is required to pass.
    3. Teaching Practice/Assignments: Internal evaluation worth 100 marks, with a minimum of 50% required to pass.
    4. Mandatory Audit Courses: These are for zero credits but are required to pass.
    5. Comprehensive Viva–Voce: This is conducted in the third semester.
    6. Project/Research Work:
  • The project begins in the third semester and spans two semesters.
  • Total evaluation for the project is 300 marks: 200 marks for internal evaluation (100 marks each for Project Work I & II in the third and fourth semesters) and 100 marks for external evaluation (final project viva voce in the fourth semester).