Syllabus of Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)

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Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) is a four-semester regular postgraduate course that drives the Research and Development efforts of the pharmaceutical companies to the market. The minimum educational qualification for getting admission into the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course is a minimum aggregate score of 45% in B.Pharm from a recognized University. 


Drug Regulatory Affairs is a crucial component of the pharmaceutical industry as it increases global competitiveness among pharmaceutical companies. Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) is a 2-year full-time postgraduate course that aims towards a comprehensive education in gaining Regulatory and Quality Compliance in the pharmaceutical industry.


The detailed syllabus of the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course as per all the four semesters is mentioned below:



SEMESTER I

SEMESTER II

National Regulatory Affairs

International Regulatory Systems

Pharmaceutical Regulatory Affairs

Clinical Trials & Healthcare Policies

Drug Approval & International Drug Regulations

Modern Analytical Techniques II

Modern Analytical Techniques I

Regulatory Aspects of Controlled Drug Delivery System

National Regulatory Affairs Lab

Modern Analytical Techniques Lab II

Pharmaceutical Regulatory Affairs Lab

International Regulatory Systems Lab

Drug Approval & International Drug Regulations Lab

Regulatory Aspects of Controlled Drug Delivery System Lab

Modern Analytical Techniques Lab I

Clinical Trials & Healthcare Policies Lab

Communicational Skills I

Communicational Skills II

Behavioural Science I

Behavioural Science II

Foreign Language I

Foreign Language II

SEMESTER III

SEMESTER IV

Biostatics & Computer Applications

Quality Assurance GLP GMP and Validation

GLP, GMP, Quality Assurance & Validation

Pharmaceutical Biostatics and Computer Applications

Biostatics & Computer Applications Lab

Professional Communication Skills

Communicational Skills III

Professional Competencies and Career Development 

Major Project Protocols & Synopsis

Synopsis

What are the Future Scopes of Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?


Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) is a specialized course that provides several opportunities to the young aspirants. Some of the most popular job profiles that a professional of Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) can opt for are as follows:


  • To pursue Professionalism in National and International Universities.

  • Research Position in R & D Departments of Central Laboratories, and Universities.

  • Opportunities in Entrepreneurship in the Medical Sector.

  • Research & Development in Pharmaceutical and Biotechnology.

  • Research & Development in Production & Analytical Marketing.

  • Dealing with the Market Research, and Regulatory Affairs.

  • Growth Opportunities in Hospitals, Pharmacists, Clinical Research.

  • Quality Assurance Inspector & Research Associate.

  • Business Development Assistant, Manufacturing, Medical Writer. 

  • Senior Research Associate, and Medical Coder.


Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) FAQs

Here is the list of the most frequently asked questions (FAQs) related to the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs):


Ques. What is the course duration of the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) program?


Ans. Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) is a 2-year full-time postgraduate course divided across four semesters.


Ques. What is the average tuition fee charged for the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course in India?


Ans. The average tuition fee charged for the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course in India ranges between INR 72,000 and 5,20,000.


Ques. Is there any entrance exam for admission to the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?


Ans. There are a few entrance exams for admission to the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) as mentioned below;


  • College of Medicine and Health Sciences (SRM Medical Entrance Exam)

  • Indukaka Ipcowala College of Pharmacy

  • Bharati Vidyapeeth Entrance Exam 

  • Lovely Professional University Entrance Exam


Ques. What is the educational qualification required for admission to the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?

 

Ans. To get admission to the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course, candidates must have passed bachelor’s degree in pharmacy (B.Pharm) with minimum 45% marks in aggregate from a recognized University.


Ques. What is the admission procedure to get enrolled with the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course?


Ans. The admission procedure to get enrolled with the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) course differs from college to college. Few colleges conduct entrance exams, whereas, few colleges admit students on the basis of merit. Therefore, candidates are advised to visit the website of their preferred college to get to know in detail about the admission process.


Ques. What are some of the best colleges for pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?


Ans. Here is the list of the best colleges for pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs).


  • Maharishi Dayanand University

  • Manipal University

  • Amity University

  • Lovely Professional University

  • Bharati Vidyapeeth

  • Vijaya College of Pharmacy

  • College of Medicine and Health Sciences

  • Nitti Gulabi Shetty Memorial Institute of Pharmaceutical Sciences


Ques. What is the course suitability of the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)? 


Ans. Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) helps to realize a pool of competent professionals in Pharmaceutical Regulatory Affairs. The course is highly significant to inculcate quality inputs in Pharmaceutical Regulatory Affairs and to interpret research writing expertise in Pharmaceutical Regulatory Affairs.


Ques. How is the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) Course Beneficial for the Medical Professionals?


Ans. The Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) Course is highly beneficial for the Medical Professionals to compete with the skills, and knowledge of collecting, communicating, and analyzing the risks and benefits of health care products to public as well as regulatory agencies throughout the world.


Ques.  What are various employment areas after pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?


Ans. There are various employment areas available after pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) like;


  • Employment Opportunities in Clinical Research Institutes

  • International Colleges & Universities

  • Careers in International Laboratories

  • Pharmaceutical Industries


Ques. What are the different types of jobs available for candidates pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs)?


Ans.  Various types of jobs available for candidates pursuing the Master of Pharmacy [M. Pharm] (Drug Regulatory Affairs) are as follows:


  • Quality Control/Quality Assurance

  • Drug Inspector/Drug Controller

  • Regulatory Affairs Consultant

  • Drug Safety Specialist

  • Medical Information Associate

  • Regulatory Administrator

  • Regulatory Affairs Assistant/Specialist

  • Regulatory Affairs Head/Director

  • Regulatory Compliance Manager

  • Regulatory Food Safety Scientist

  • Regulatory Affairs Associate

  • Medical Information Associate

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