Master of Pharmacy in Pharmaceutical Regulatory Affairs

Master of Pharmacy in Pharmaceutical Regulatory Affairs
Accreditations
Accreditations at SGT
 Pharmacy Accreditations
Pharmacy Council India

Course Details

M Pharm in Pharmaceutical Regulatory Affairs Course

The Master of Pharmacy (M Pharm) in Pharmaceutical Regulatory Affairs at SGT University is a 2-year postgraduate program that offers advanced knowledge and research skills in this specialised pharmacy field. This course equips students with comprehensive regulatory expertise for registering pharmaceuticals and medical devices in Indian and international markets.

The program emphasises developing research skills. Students conduct research projects under faculty guidance to gain more profound expertise. This hands-on approach prepares graduates to tackle the complex challenges of the pharmaceutical industry, focusing on navigating diverse regulatory landscapes.

M Pharm in Pharmaceutical Regulatory Affairs Syllabus

The Master of Pharmacy (M Pharm) program typically includes Pharmaceutical Regulatory Affairs in its curriculum. The M Pharm in Pharmaceutical Regulatory Affairs syllabus at SGT University provides both theoretical knowledge and practical research skills. Key areas of study include:

  • Fundamentals of Regulatory Affairs
  • Drug and Medical Device Registration Processes
  • Indian and International Regulatory Guidelines
  • Regulatory Documentation and Submissions
  • Clinical Research Regulations
  • Quality Management Systems
  • Research Methodology and Scientific Writing

A significant portion of the program focuses on a research project, allowing students to explore specific areas of pharmaceutical regulatory affairs under faculty supervision.

Studying Pharmaceutical Regulatory Affairs as part of the M Pharm program prepares students for roles in pharmaceutical companies, regulatory agencies, or consulting firms, where they oversee the development and marketing of new drugs and medications.

M Pharm in Pharmaceutical Regulatory Affairs Subjects

The Master of Pharmacy (M Pharm) program is a specialised postgraduate course in pharmaceutical sciences. Pharmaceutical Regulatory Affairs (PRA), a key subset of pharmaceutical sciences, focuses on regulating pharmaceutical products. In an M Pharm program with a specialisation in PRA, students explore subjects such as:

  • Pharmaceutical Regulatory Affairs (Indian and International)
  • Drug and Medical Device Regulatory Affairs
  • Clinical Trial Regulations
  • Regulatory Writing and Documentation
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
  • Research Project in Regulatory Affairs

Each subject enhances students' research abilities and regulatory knowledge, preparing them for academia, industry, or consulting roles. These subjects equip students for careers in pharmaceutical regulatory agencies, the pharmaceutical industry, or consulting firms.

Top Pharmaceutical Regulatory Affairs Colleges in India

SGT University ranks among India's top institutions for Pharmaceutical Regulatory Affairs, offering a distinguished M Pharm in Pharmaceutical Regulatory Affairs. The university's commitment to advanced research and specialised regulatory knowledge sets it apart. Key features include:

  • A curriculum that covers both Indian and international regulatory landscapes
  • State-of-the-art research facilities
  • Faculty with expertise in regulatory affairs and research
  • Emphasis on developing research skills through guided projects
  • Opportunities for internships and industry exposure
  • Focus on practical applications of regulatory knowledge

Graduates from SGT University's M Pharm in Pharmaceutical Regulatory Affairs program are well-prepared for roles in pharmaceutical companies, regulatory agencies, and research institutions, armed with a solid foundation in regulatory knowledge and research methodologies. This program structure ensures students acquire theoretical knowledge and critical research skills essential for advancing the field of pharmaceutical regulatory affairs.

Quick Facts

The Master of Pharmacy in Drug Regulatory Affairs (M Pharm in Drug Regulatory Affairs) is a specialized 2-year program focused on equipping students with the knowledge and skills required to navigate the complex regulatory environment of the pharmaceutical industry. This course covers all aspects of drug regulation, ensuring that students are well-prepared for critical roles in the industry.

M Pharm in Drug Regulatory Affairs: Course Highlights


Particulars Details
Duration 04 Semesters, 02 years
Course Fees INR 1,50,000 (per annum)
Eligibility
  • Degree: B. Pharmacy
  • Minimum Marks Required: 55%
  • For SC/ST Candidates: 50%
  • For Professionals: 5 years of experience after B. Pharm.
Top Job Profiles Regulatory Affairs Officer, Pharmacovigilance Specialist, Clinical Research Associate, Medical Writer, Quality Assurance/Quality Control Officer, Drug Safety Associate, Clinical Data Manager, Pharmaceutical Industry Researcher, Medical Coder, etc.
Top Job Recruiters Amneal Pharmaceuticals, Bristol Myers Squibb, Medtronic, Merck Limited, Aurobindo Pharma, Zydus Lifesciences, Abbott, IPCA Laboratories, etc.

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