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M. Pharm. in Drug Regulatory Affairs is a 2-year full-time postgraduate course, the minimum eligibility for admission to which is the successful completion of graduation, from a recognized university, and with a minimum aggregate score of 45%.

The program is spread over 4 semesters, with the final involving substantial project work.

Admission to the course is often based on the candidate’s obtained merit at the level of graduation, and often, on the candidate’s performance in a relevant entrance test.

Such postgraduates are hired in capacities such as:

  • Regulatory Affairs Consultant
  • Regulatory Affairs Specialist
  • Regulatory Affairs Associate
  • Drug Safety Specialist
  • Drug Inspector
  • Quality control Associate
  • Food Safety Scientist
  • Medical Information Associate, and such.

The average tuition fee charged for the course in India ranges between INR 72,000 and 5,20,000 for a span of 2 years, and the average annual salary offered to such professionals ranges between INR 3.5 and 7 Lacs, increasing with experience and expertise.

Top Colleges for Master of Pharmacy [M.Pharm] (Drug Regulatory Affairs)

  • Master of Pharmacy [M.Pharm] (Drug Regulatory Affairs) in Andhra Pradesh
  • M.Pharm in Delhi-NCR
  • M.Pharm in Maharashtra
  • M.Pharm in Chennai
  • M.Pharm in Uttar Pradesh
  • M.Pharm in Telangana

M. Pharm. in Drug Regulatory Affairs: Course Highlights

Listed below are some of the major highlights of the course.

Course LevelPostgraduate
Duration2 years
Examination TypeSemester system
EligibilityGraduation in any stream, completed from a recognized university, with a minimum aggregate score of 45%
Admission ProcessMerit-based/ Based on performance in entrance exam
Course FeeINR 72,000 to 5,20,000
Average Starting SalaryINR 3.5 to 7 lacs per annum
Top Recruiting CompaniesSun Pharma, Glanmark, Biocon, GlaxoSmith Pharmaceuticals, and such.
Top Recruiting AreasPharmaceutical companies, overseas firms, clinical research institutes, colleges and universities, etc.
Top Job ProfilesRegulatory Affairs Consultant, Regulatory Affairs Specialist, Regulatory Affairs Associate, Drug Safety Specialist, Drug Inspector, Quality control Associate, Food Safety Scientist, Medical Information Associate, among others such.

M. Pharm. in Drug Regulatory Affairs: What is it About ?

M. Pharm. in Drug Regulatory Affairs is spread over 4 semesters, and essentially aims to offer to eligible candidates advanced lessons in:

  • Regulatory and Quality Compliance in the pharmaceutical industry
  • Pharmaceutical Regulatory Affairs
  • National and International Drug Approvals & Bio-ethics
  • Modern Analytical Techniques
  • Research Methodology & Pharmacological Screening
  • International Regulatory Systems
  • Clinical Trials & Healthcare Policies
  • National Regulatory Affairs
  • Emerging Concept in Regulatory Affairs
  • Quality Assurance GLP
  • GMP & Validation
  • Drug Regulatory Affairs
  • Intellectual Property Rights & Bioethics
  • Pharmaceutical Biostatistics & Computer Applications
  • Current regulations and their practical applications in development and commercialisation of drugs, biologics, and also, related medical devices
  • bringing a medical product to market around the globe, from discovery to commercialization.

Laboratory sessions and research in the discipline include the following:

  • International Regulatory Systems Lab
  • Clinical Trials & Healthcare Policies Lab
  • National Regulatory Affairs Lab
  • Emerging Concept in regulatory Affairs Lab
  • Pharmaceutical Regulatory Affairs Lab
  • National & International Drug Approvals & Bio-ethics Lab.

Drug Regulatory Affairs is a major component of the pharmaceutical industry, since:

  • It drives the Research and Development efforts of the company to the market.
  • With increasing global competitiveness among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the regulatory agencies of the region where the drug is to be sold.

The course also includes substantial project work including patents, thesis, publications, and dissertations, needed to be completed by enrolled students.

Top Institutes offering M. Pharm. in Drug Regulatory Affairs

Listed below are some of the top institutes in India that offer the course.

Name of InstituteCityAverage fees
College of Medicine and Health SciencesChennaiINR 1,60,000 (course)
Nitti Gulabi Shetty Memorial Institute of Pharmaceutical SciencesMangaloreINR 1,10,000 (course)
Indukaka Ipcowala College of PharmacyGujaratINR 81,000 (course)
AKS UniversitySatnaINR 1,30,000 (course)
Vijaya College of PharmacyHyderabadINR 1,10,000 (course)
Maharishi Dayanand UniversityRohtakINR 70,000 (course)
Ch. Bansilal UniversityBhiwaniINR 74,000 (course)
Bharati VidyapeethPuneINR 2,20,000 (course)
Amity UniversityNoidaINR 3,20,000 (course)
Manipal UniversityManipalINR 5,20,000 (course)
Lovely Professional UniversityJalandharINR 3,30,000 (course)

Eligibility for M. Pharm. in Drug Regulatory Affairs

Candidates wishing to apply for the course need to fulfil the following eligibility criteria:

  • Graduation (preferably B. Pharm.) completed from a university recognized by the Pharmacy Council of India.
  • A minimum aggregate score of 50% (45% for SC/ST/OBC candidates) at the level of graduation.
  • Candidates awaiting their graduation-level examination’s results are also eligible to apply on provisional basis.

M. Pharm. in Drug Regulatory Affairs: Admission Process

Most institutes in India offering the course admit students based on their performance in a relevant entrance test. Some institutes also admit students based on the candidate’s obtained merit at the level of graduation, while some conduct their own entrance tests for offering admission. Admission process generally varies across colleges.

Some such institutes in the country that conduct entrance tests for admission to the course are:

  • College of Medicine and Health Sciences (SRM Medical Entrance Exam)
  • Indukaka Ipcowala College of Pharmacy
  • Lovely Professional University
  • Bharati Vidyapeeth

M. Pharm. in Drug Regulatory Affairs: Syllabus and Course Description

A semester-wise breakup of the course’s syllabus is tabulated here.

Semester I

Semester II

Cosmetic TechnologyClinical Trials and Healthcare Policies
Natural Products and Herbal MedicinesEmerging Concept in Regulatory Affairs
Modern Analytical TechniqueNational Regulatory Affairs
Research Methodology and Pharmacological ScreeningInternational Regulatory Systems
Pharmaceutical Regulatory AffairsNational and International Drug Approvals and Bioethics

Semester III

Semester IV

Fundamentals of Medical and Scientific Writing Quality Assurance GLP GMP and Validation
Pharmaceutical Production and Management Pharmaceutical Biostatics and Computer Applications
Natural Products and Herbal MedicinesProfessional Communication Skills
Nutraceuticals Professional Competencies and Career Development 
-Synopsis

M. Pharm. in Drug Regulatory Affairs: Career Prospects

The course produces trained professionals who can skilfully deliver in job roes such as:

  • Regulatory Affairs Specialist
  • Assistant Project Manager
  • Associate Scientist
  • Bio-technician
  • Change Control Specialist
  • Technical Engineer
  • Stability Specialist
  • Medical Affairs Associate
  • Research Associate
  • Quality Systems Engineer
  • Quality Assurance Associate.

Professionals engaged in Drug Regulatory Affairs regularly interact with other teams in the organization to get documents such as batch records, production equipment information, packaging specifications, and technical reports.

M. Pharm. postgraduates can also explore teaching as a career option, and upon qualification of examinations such as GPAT, NET, and SLET.

Andhra Pradesh, Karnataka, Gujarat, Haryana, Madhya Pradesh, Maharashtra, Tamil Nadu, Punjab, Rajasthan, Uttar Pradesh, and Kerala are the States in India to have pharmacy colleges in the range of 60 – 200.

Some of the popular professional avenues open to successful postgraduates of the course are listed below with the corresponding salaries offered for the respective positions.

Job PositionJob DescriptionAverage Annual Pay in INR
Drug Safety SpecialistDrug Safety Specialists are vital to the pharmaco-vigilance department in operating its daily activities. Essentially, Drug Safety Associates oversee drug-related events to be identified and reported. Drug Safety Associates liaise with healthcare service providers for safety and efficacy aspects. They are responsible for ensuring that most safety reports received from the investigational sites or from post-marketing sectors are identified and reported in accordance with ICH-GCP standards as also with the standard operational procedures.6 lacs
Regulatory Affairs AssociateThe job title ‘Regulatory Affairs Associate’ is used most frequently for entry-level, mid-level, and senior professionals working within the health care products industry. They are responsible for monitoring federal, State, and local government regulations, legislation, and laws that affect their employers' products. They typically assist other employees in steering new products through government-authorized approval processes and watch their organization’s internal procedures to ensure that they conform to government directives. Regulatory Affairs Associates are often employed by pharmaceutical or medical device companies, for assisting in obtaining government approval for drugs, medical devices, veterinary products, cosmetics, and food products. Regulatory Affairs Associates occupy one career niche within the larger regulatory affairs profession, which exists in many industries.4 lacs
Drug InspectorDrug Inspectors, also known as Quality Control Inspectors, work to ensure that products are safe for human consumption. Their main responsibility is to examine food or pharmaceuticals at various stages of the manufacturing process in order to ensure that the requisite quality standards are being met. Such professionals also take on advanced positions as Consumer Safety Officers responsible for implementing safety procedures and designing inspection techniques for pharmaceutical products. They require excellent oral and written communication skills, problem-solving and decision-making skills, strong operation-monitoring and analytical abilities, and familiarity with digital imaging, data analysis, and tolerance analysis software. Also, they must be deft at using weights, scales, and sorting or grading machines.7 lacs
Medical Information AssociateAlso known as Health Information Technicians, these professionals organize and maintain health data in electronic and paper systems within various healthcare settings. They are responsible for reviewing patient records, organizing databases, tracking patient outcomes and protecting patients' health information. Such professionals work in hospitals, physicians' offices, residential care facilities, and government agencies. They must possess good clinical knowledge and experience of working in a hospital environment, and research-based roles, besides therapy-related knowledge that can convert well in the medical information industry.3.5 lacs

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