M.Pharm Drug Regulatory Affairs Course - Admission, Eligibility, Fees, Duration, Syllabus, Job & Salary
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M.Pharm Drug Regulatory Affairs Course - Admission, Eligibility, Fees, Duration, Syllabus, Job & Salary

14 Apr,2020

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M.Pharm Drug Regulatory Affairs Course:

M.Pharma Drug Regulatory Affairs Course is also known as the Master of Pharmacy in Drug Regulatory Affairs Course. It is a 2-year full-time postgraduation course which is of 4th semesters in total. This course is designed to provide all the comprehensive knowledge and education regarding the entire Regulatory and quality compliance aspects of the pharmaceutical industry. Students are taught to nurture their knowledge of regulation and compliance and also to build their careers in the same. The ever-changing laws and regulatory affairs have raised the demand of the professionals that can help the pharmaceutical companies to launch the product in the market.

M.Pharm Drug Regulatory Affairs Course Suitability:

  1. This course is helpful to produce competent professionals in the pharmaceutical regulatory affairs industry.
  2. This course is helpful to provide quality inputs to the pharmaceutical regulatory affairs industry and to build the research writing and documentation expertise in the pharmaceutical regulatory affairs industry.

M.Pharm Drug Regulatory Affairs Course:

This course is beneficial as it deals with the knowledge and the skills of collection, analysis, and communication regarding the risk and benefits of health care products the regulatory agencies and the people all over the world.

M.Pharm Drug Regulatory Affairs Course Brief:

Some of the major highlights of the course are enlisted as follows-

Level of the course

Postgraduate Level

Duration of the course

2 years divided into 4 semesters

Type of examination

Semester examination system

Eligibility Criteria

Graduation in the Pharmaceutical stream or preferably science stream, completed from a recognized institute or university, with a minimum aggregate score of 50% or as stated and required by the university.

Process of admission

Merit-based or Based on the performance in the entrance exam

Fees of the course

INR 80,000 to 5,50,000

Approx Starting Salary

INR 3lac to 8 lacs per annum

Top Recruiters or Companies

GlaxoSmith Pharmaceuticals, Cipla, Sun Pharma, Himalaya, Glenmark, Biocon, etc.

Top Recruiting Domains

Pharmaceutical Laboratories, Pharmaceutical companies, overseas firms, clinical research institutes, colleges, and universities, etc.

Top Job Designation

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

M.Pharma Drug Regulatory Affairs Course Admissions:

Most of the institutes in India offer this course to admit students based on their performance in a relevant entrance test. Some institutes also admit the students based on their obtained marks in the merit at the level of graduation, while some of the colleges or the universities conduct their own entrance tests for offering admission. The admission process usually varies across colleges as each college has its own admission criteria.

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

  • College of Medicine & Health Sciences also known as SRM Medical Entrance Exam
  • Indukaka Ipcowala College of Pharmacy
  • Lovely Professional University
  • Bharati Vidyapeeth

M.Pharma Drug Regulatory Affairs Course Fees

The course fees for Master of Pharmacy or M.Pharma Drug Regulatory Affairs Course Fees range from INR 80000 to 5.5 Lakh per annum. The fees may vary across the colleges based on the infrastructure and the facilities provided by the college/university.

M.Pharma Drug Regulatory Affairs Course Duration:

M.Pharma Drug Regulatory Affairs Course Duration is of 2 years and this course is divided into 4 semesters of 6 months each duration. One academic year of the course consists of 2 semesters each.

M.Pharma Drug Regulatory Affairs Course Scope:

The M.Pharma Drug Regulatory Affairs Course Scope is really wide as it produces the trained professionals who can skilfully deliver in job roles such as:

  • Regulatory Affairs Expert
  • Assistant Project In-Charge
  • Assistant Scientist
  • Bio-tech expert
  • Change Control expert
  • Tech Engineer
  • Stability Expert
  • Medical Affairs Expert
  • Research Assistant
  • Quality System Engineer
  • Quality Assurance Assistant.

Professionals involved in Drug Regulatory Affairs constantly interact with other teams in the organization to get documents such as-

- batch records, 

- production equipment information,

- packaging specifications, and 

- technical reports.

M.Pharma postgraduates can also traverse teaching as a career option upon the qualification of examinations such as NET, GPAT, & SLET. Karnataka, Andhra Pradesh, Haryana, Gujarat, Madhya Pradesh, Tamil Nadu, Maharashtra, Punjab, Rajasthan, Uttar Pradesh, and Kerala are the States in India to have pharmacy colleges.

Job Designation

Description of the job

Approx.Annual Pay in INR

Drug Safety Expert

Drug Safety Experts are necessary to the pharmaco-vigilance department in performing its daily activities. Basically, Drug Safety Associates supervise drug-related events to be identified & reported. Drug Safety Associates liaise with healthcare aid providers for safety & efficiency aspects. They are accountable for ensuring that most safety reports received from the investigational sites or from post-marketing sectors are recognized and reported in accordance with ICH-GCP standards as also with the standard operational methods.

7.5 lacs

Regulatory  Affairs Assistant

The job title ‘Regulatory Affairs Assistant’ is used most frequently for entry-level, mid-level, &senior professionals functioning within the health care products industry. They are accountable for observing federal, state, & local government regulations, legislation, & laws that affect their employers' products. They basically assist other operators in steering new products through government-authorized permitted processes and watch their organization’s internal systems to ensure that they adhere to government directives. Regulatory Affairs Assistants are usually employed by pharmaceutical or medical device companies, for assisting in attaining government approval for drugs, medical devices, veterinary products, cosmetics, & food products. Regulatory Affairs Assistant occupies one career inside within the larger regulatory affairs profession, which exists in many industries.

5 lacs

Drug Inspectors

Drug Inspectors know as Quality Control Inspectors, work to guarantee that medical products are safe for human consumption. Their focal job is to examine food or pharmaceuticals at different stages of the manufacturing method in order to ensure that the requisite quality standards meeting. These experts have also held senior positions as consumer safety officers, responsible for implementing safety procedures and designing drug inspection technologies. They require-

- excellent oral & written communication skills, -problem-solving & decision-making skills,

- strong operation-monitoring & analytical abilities, & -familiarity with digital imaging, data analysis, & 

-tolerance analysis software. 

In addition, they must be smart when using the weights, balances, & sorting or grading machines.



8 lacs

Medical Information Assistant

They are also known as Health Information Technicians, these professionals design & maintain health data in electronic & paper systems within several healthcare settings. They are accountable for-

- reviewing patient records, 

- organizing databases, 

- tracking patient outcomes and

- protecting patients' health information. 

Such experts work in hospitals, physicians' offices, residential care facilities, & government agencies. They must hold good clinical knowledge & experience of working in a hospital environment, & research-based roles, besides that therapy-related knowledge that can turn well in the medical information industry.

4.5 lacs

M.Pharm Drug Regulatory Affairs Course Colleges:

M.Pharma Drug Regulatory Affairs Course Colleges are listed below. Some of the top institutes in India that offer this course are as follows.

Name of College

Place

Approx fees

College of Medicine & Health Sciences

Chennai

INR 1,80,000 

Nitti  Gulabi Shetty Institute of Pharmaceutical Sciences

Mangalore

INR 1,20,000 

Indukaka Ipcowala College

Gujarat

INR 91,000 

AKS University

Satna

INR 1,50,000 

Vijaya College 

Hyderabad

INR 1,20,000 

Maharishi Dayanand University

Rohtak

INR 80,000 

Ch. Bansilal University

Bhiwani

INR 78,000 

Bharati Vidyapeeth

Pune

INR 2,40,000

Amity University

Noida

INR 3,50,000 

Manipal University

Manipal

INR 5,50,000

Lovely Professional University

Jalandhar

INR 3,50,000 

M.Pharma Drug Regulatory Affairs Course Syllabus:

M.Pharma Drug Regulatory Affairs Course Syllabus is spread over 4 semesters, & essentially proposes to offer to eligible candidates advanced lessons in:

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

Laboratory sessions & research in the discipline include the following:

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

Drug Regulatory Affairs is an important constituent of the pharmaceutical industry, since:

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

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

A semester-wise bifurcation of the course’s syllabus is tabulated below.

Semester I

Semester II

Cosmetic Technology

Clinical Trials & Healthcare Policies

Natural Products & Herbal Medicines

Emerging Notion in Regulatory Affairs

Modern Analytical Procedures

National Regulatory Affairs

Research Methodology & Pharmacological Screening

International Regulatory Systems

Pharmaceutical Regulatory Affairs

National & International Drug Approvals & Bioethics

Semester III

Semester IV

Basics of Medical & Scientific Writing 

Quality Assurance GLP GMP & Validation

Pharmaceutical Production & Management 

Pharmaceutical Biostatics & Computer Applications

Natural Products & Herbal Medicines

Professional Communication Skills

Nutraceuticals Theory 

Professional Competencies & Career Development 

-

Synopsis Viva-Voice

M.Pharm Drug Regulatory Affairs Course Jobs:

M.Pharma Drug Regulatory Affairs Course Jobs are enlisted below. M.Pharma Drug Regulatory Affairs postgraduates are hired in capacities such as:

  • Regulatory Affairs Adviser
  • Regulatory Affairs Expert
  • Regulatory Affairs Assistant
  • Drug Safety Expert
  • Drug Inspector
  • Quality control Assistant
  • Food Safety Specialist
  • Medical Information Assistant.

Master of Pharmacy proposes various specializations with which one can choose his most liked field. Master of Pharmacy grants better display to practical skills. It enables one to study Ph.D. (Pharmacy) in-

- Pharmaceutics, 

-Pharmaceutical Chemistry, 

-Pharmacology, 

-Pharmaceutical Marketing & Management.

Some of the job sectors which an M.Pharm Candidate can locate are:

  • Health care Centres
  • Hospitals and medical centers
  • Pharmacy Shops
  • Drug Control Department
  • Pharmaceutical Companies
  • Educational colleges and institutes
  • Sales & Marketing Department
  • Research centers
  • Food & Drug Administration

M.Pharma Jobs for Freshers:

Some of the job opportunities for Freshers of M.Pharma course are enlisted below:

  • Drug Examiner
  • Pharmacy owner 
  • Research professional
  • Lab Scientist
  • Pathologist technician
  • Research & Development Executive
  • Medical Representatives 
  • Medical Coder

M.Pharma Government Sector Jobs:

The jobs which can be founded by an M.Pharma graduate in the public sector are enlisted below:

  • Research Inquisitor
  • Drug Control officer
  • Pharmacy owner
  • Pharmaceutical Research Assistant
  • Medical Representative
  • Medical Coder
  • Professor/teacher
  • Production Supervisor

M.Pharm Private Sector Jobs:

Various job possibilities are available for M.Pharma postgraduates in the private sector. The jobs which can be founded are enlisted below:

  • Drug Therapist
  • Pharmacist
  • Medical Representative
  • Drug Analyst 
  • Research Scientist
  • Medical Coder
  • Drug Controller
  • Production Manager

Salary Scale for M.Pharma Course Professionals:

The approx salary for a graduate of the M.Pharma Course is INR 2.5 to 4 LPA. This may be different based on the experience of the candidates. The salary & incentives would be increased based on the performance and experience of the candidate.

CONCLUSION-

Dear Aspirants, we have tried our best to share and bring out a clear picture of the M.Pharma Drug Regulatory Affairs Course keeping in front of you almost all the aspects of the course discussing each and every detail, so that you students can get all the information regarding the course under one roof. This is also to help in the calculative and most accurate decision-making process regarding the career & future shaping of the students.

So here we have provided you with all the details regarding M.Pharma Drug Regulatory Affairs Course Admission,  M.Pharma Drug Regulatory Affairs Course Fees, M.Pharma  Drug Regulatory Affairs Course Duration, M.Pharma Drug Regulatory Affairs Course Scope, M.Pharma Drug Regulatory Affairs Course Syllabus, M.Pharma Drug Regulatory Affairs Course Colleges, M.Pharma Course Jobs. We wish you all students the best for your bright future and really hope that all the aspirants are benefited from this information.

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